Clinical Data

A Gynaecological Case Report Using a Unique Laparoscope Lens Cleaning Device OpClear®
22 Aug 2024

During challenging laparoscopic procedures maintaining clear vision is critical to the outcome – A Gynaecological case report using a unique Laparoscope lens cleaning device OpClear®

A 44 year para 1 (LSCS) old woman presented to her GP with sudden onset and worsening pain in her right iliac fossa. She was referred to the oncall surgical team with a suspected diagnosis of a perforated appendix. A subsequent CT of the abdomen & pelvic revealed an inflammatory mass in the right adnexa which appeared to be related to the ovary (figure1). The appendix was seen superiorly to this abnormality and appeared normal. She was then referred to the oncall gynaecology team with a diagnosis of a right tubo-ovarian abscess. The oncall team commenced her on intravenous antibiotics and requested a pelvic ultrasound. A transvaginal scan was undertaken but was difficult given the patient’s body mass index of 53 (weight 131kg). Nonetheless the sonographer reported a 76mm complex cystic structure (figure2), with a medium to large amount of free fluid in the pouch of Douglas (POD). The uterus and left ovary were reported as normal. After 24 hours the patient was switched to oral antibiotics, she continued to improve clinically and was subsequently discharged home.

Of note, earlier in the year she had been referred for investigation and management of her heavy menstrual bleeding. She was keen to pursue surgical options but given her morbid obesity, she was advised that this would only be possible if she lost a significant amount of weight. One week following her discharge she was re-admitted with a recurrence of right iliac fossa pain. A repeat pelvic ultrasound revealed an increase in size of the pelvic mass to 86x50x92mm, again with free fluid but this time low level mobile echoes were also visible (figure 3). After discussions with microbiology she was once again commenced on intravenous antibiotics but to be continued for 10 days. If after 10 days a further pelvic ultrasound showed no change in size, she was to be booked for elective surgery.

challenging laparoscopic procedures maintaining clear vision is critical to the outcome

Ten days later she was clinically well, but a repeat ultrasound suggested no change in the size of her adnexal mass. She was therefore booked for elective surgery and consented for a laparoscopic and or open incision and drainage of her tubo-ovarian abscess. However she was very insistent that if at all possible could her “womb be removed at the same time”, as her family was complete and her periods were “terrible”. She was therefore consented for a total laparoscopic hysterectomy and removal of fallopian tubes and right ovary.

Under general anaesthesia, a 20mm pneumoperitoneum was created with a standard verres entry technique. A 12mm trochar was then inserted into the umbilicus to facilitate the use of the OpClear® device with a 10mm zero degree laparoscope. The OpClear® was primed prior to insertion into the abdomen. Given the patient’s morbid obesity the anaethestist was reluctant to have a steep trendelenberg “head down” position, because of the increase in ventilation pressures. This further increased the technical complexity of laparoscopic surgery. Despite the difficulties insertion of the laparoscope into the abdomen revealed a right tubo-ovarian mass, with a large pseudocyst and fluid in the POD. To facilitate the surgery and retract the bowel, four 5mm ports (two in each lower quadrant) were inserted. The right adnexa was mobilised with blunt dissection and utilising the Thunderbeat TM device. The Opclear® significantly and consistently maintained good surgical acuity. With the adnexa excised the decision was taken to go on and perform a total laparoscopic hysterectomy as per the patient’s request. This was only made in the context of a reliable surgical field of view. Given the adiposity, proximity of the bowel, adhesions from the previous LSCS , this was a high risk procedure, with potential bowel, bladder and ureteric complications.

The dissection of the left adnexa and reflection of the bladder was unremarkable, however the right uterine artery started to bleed when divided by the Thunderbeat TM device. It retracted. Once again good surgical acuity provided by the OpClear® device facilitated identification of the bleeding vessel and the adjacent anatomy. Once haemostasis was secured a colpotomy was performed, the uterus and specimen were removed vaginally and then the vault was closed with intracorporeal laparoscopic suturing using the Stratofix TM suture. As a precaution given the proximity of the right ureter a retrograde pyelogram was performed. This showed good fill and spill with no suggestion of ureteric compromise.

Post operatively, the patient made an unremarkable recovery and went home 48 hours later.

Patient’s view

“As soon as I woke up, I had no pain in the right side, it was heaven. I’m so grateful. I’m over the moon. I’ve had three years of agony and pain from my periods, affecting my life, work and relations with my husband. I feel I’ve been given a new lease of life.” Mrs SE

Surgeon’s view

“This was technically challenging surgery. The patient’s morbid obesity significantly complicated the surgery. Without a constant clear image created by OpClear®, I would not have had the confidence to proceed with a total laparoscopic hysterectomy. In my opinion the improved surgical acuity delivered by the Opclear® device significantly reduced the risk of conversion to

an open procedure. Conversion to laparotomy would have increased the patient’s risk of w

ound infection, venous thromboembolism, a longer in patient stay and a much longer return to normal activities. This is an excellent example of medical device innovation, delivering real quality improvements for the patient, the hospital and commissioners of healthcare.” Mr A Alexander Taylor, Consultant

 

Clinical Data

Constant High-Level Visual Acuity During Total Laparoscopic Hysterectomy Using the OpClear® System
22 Jul 2024

Journal of Obstetrics and Gynaecology

ISSN: (Print) (Online) Journal homepage: www.tandfonline.com/journals/ijog20

R. Evans & A. Taylor
To cite this article: R. Evans & A. Taylor (2024) Constant high-level visual acuity during total laparoscopic hysterectomy using the OpClear®

system, Journal of Obstetrics and Gynaecology,

44:1, 2375590, DOI: 10.1080/01443615.2024.2375590
To link to this article: https://doi.org/10.1080/01443615.2024.2375590

View the full clinical study here: Journal of Obstetrics and Gynaecology: Constant High-level Visual acuity During Total Laparoscopic Hysterectomy Using the OpClear® System

Clinical Data

Clinical Papers and Testimonials Summary April 2024
22 Apr 2024

View Our Clinical Papers and Testimonials Summary April 2024

Clinical Papers and Testimonials Summary April 2024 Clinical Papers and Testimonials Summary April 2024

News & Events

Cipher Surgical Announces Mark Alley as Chief Executive Officer (CEO)
01 Mar 2024

[Chantilly, VA, March 1, 2024] – Cipher Surgical, a leading innovator in medical device technology, is pleased to announce a strategic leadership transition effective March 1, 2024. Mark Alley, formerly serving as the President of the U.S. division, has been appointed as the new Chief Executive Officer (CEO) of Cipher Surgical. Concurrently, Andrew Newell, the incumbent Founder and CEO, will transition to the role of Executive Chairman.

Mark Alley brings a wealth of experience and a proven track record of driving growth and innovation within the medical device sector. During his tenure as President of the U.S. division, Mark demonstrated exceptional leadership skills and a deep understanding of our industry. His appointment as CEO underscores our commitment to sustained growth and excellence in delivering cutting-edge solutions to our customers. “I am honored and excited to take on the role of CEO at Cipher Surgical,” said Mark Alley. “I look forward to leading our talented team as we continue to advance our mission of improving patient outcomes through innovation and being the new gold standard in laparoscopic lens cleaning.” Andrew Newell, who has served as Founder and CEO, and who has worked tirelessly to grow the business, will assume the role of Executive Chairman, where he will provide strategic guidance and support to the leadership team. His continued involvement will ensure a seamless transition and bolster Cipher Surgical’s strategic initiatives.

“I am proud of what we have achieved at Cipher Surgical under my leadership, and I am confident that Mark Alley is the right person to lead the company into its next phase of growth,” said Andrew Newell. “As Executive Chairman, I am committed to supporting Mark and the entire team as we work towards our shared goals.” The Board of Directors expresses its gratitude to Andrew Newell for his significant contributions as CEO and looks forward to his continued leadership as Executive Chairman. The Board extends its congratulations to Mark Alley on his appointment as CEO and has full confidence in his ability to drive Cipher Surgical’s success in the years ahead.

About Cipher Surgical:

Cipher Surgical is a medical device company established in 2010 with the goal of improving the efficiency and safety of minimally invasive surgery through the development and commercialization of products that maintain uncompromised surgical vision in Laparoscopic and Robotic Surgery procedures.

The OpClear® platform has been designed for use in laparoscopic procedures to provide continuous intra-abdominal vision to the surgical team, maintaining a surgical flow associated with fewer surgical errors and shorter operating times.

The OpClear® platform uses in-situ on demand CO2 and saline lens wash, minimizing the need for scope removal during a procedure and addressing many of the frustrations associated with visual obstructions. This rapidly clears larger visual obstructions such as blood or particles from energy plumes to provide continuous vision throughout
each procedure. For more information about Cipher Surgical, visit: www.ciphersurgical.com

Social Media: LinkedIn www.linkedin.com/company/ciphersurgical

View full press release here: Cipher Surgical Announces Mark Alley as Chief Executive Officer 3-1-24 FINAL (1)

News & Events

Mark Alley Appointed as President of Cipher Surgical Inc.
06 Jun 2023

CHANTILLY, Va., June 6, 2023 /PRNewswire/ — As US President of Cipher Surgical Inc. Mark will be responsible for all aspects of US Operations.

A proven global executive leader with extensive experience building and developing teams that consistently exceed revenue goals, Mark has a passion for assessing sales performance and leading teams thru rapid growth.

Continue Reading

Mr Alley most recently served as Vice President of Sales at Medtronic. He started his professional career at Black and Decker and subsequently also held various leadership roles at Boston Scientific, Johnson and Johnson, Spirox, Entellus Medical, Stryker, Levita Magnetics and Intersect ENT.

“We are delighted to have attracted such a high calibre executive in Mark to manage our US operations” said Andrew Newell, Cipher Surgical’s CEO “At this point in the OpClear’s® development towards adoption as a new gold standard in laparoscopic lens clearing, we are experiencing significant interest in the OpClear® from the US surgical community. Mark’s management and commercial expertise and experience in surgical devices will be essential to drive sales of the OpClear® through our direct sales team and 3rd parties, to fully utilise our operational partnership with MSI out of Chantilly and to develop strategic alliances.”  

About Cipher Surgical

Cipher Surgical is a British company established in 2010 with the goal of improving the efficiency and safety of minimally invasive surgery through the development and commercialisation of products that maintain uncompromised surgical vision.

The OpClear® platform, launched in 2013, protects the laparoscope’s lens from condensation and particulates through an intelligent CO2 flow at its tip and removes visual obstructions with an on demand CO2 and saline lens wash, allowing procedures to continue with minimal disruption.

Cipher Surgical is focused on research and development, investing 35% of expenditure annually. Projects include clinical research to validate the impact of the OpClear® platform on patient outcomes. This work enables physicians and hospitals to make evidence-based decisions.

Their goal is to make in-situ lens cleaning the standard of care by scientifically demonstrating its true value to healthcare systems worldwide. For more information, visit www.ciphersurgical.com.

Social Media:
LinkedIn: www.linkedin.com/company/ciphersurgical
Twitter: @Cipher_Surgical

SOURCE Cipher Surgical Inc.

 

Clinical Data

Abstract: Stop the Smudge: A Novel Solution to Loss of Vision During Laparoscopic Colorectal Surgery
25 Aug 2022

Title: Stop the Smudge: A Novel Solution to Loss of Vision During Laparoscopic Colorectal Surgery

Authors: Ozgur, Ilker MD; Liska, David MD; Valente, Michael A. MD; Steele, Scott R. MD; Gorgun, Emre MD
Published: Surgical Laparoscopy, Endoscopy & Percutaneous Techniques: August 25, 2022 – Volume – Issue – 10.1097/SLE.0000000000001091
Background: 

An obscured vision of surgical field during laparoscopic surgery is inconvenient. Several temporary methods were described as solutions to loss of vision, and common practice is scope removal, cleaning, and heating. A lately developed and introduced device claims continuous clear vision during laparoscopic surgery. This study aims to present our initial experience with the device during laparoscopic colorectal surgery.

View the full abstract here: https://journals.lww.com/surgical-laparoscopy/abstract/2022/10000/stop_the_smudge__a_novel_solution_to_loss_of.5.aspx

Download the full article here: https://ciphersurgical.com/wp-content/uploads/2022/08/Stop_the_Smudge__A_Novel_Solution_to_Loss_of.35.pdf  

Clinical Data

Retrospective Study of Operating Efficiency in Laparoscopic Hysterectomy Using the OpClear® System
24 Aug 2022
Title: Retrospective study of operating efficiency in laparoscopic hysterectomy using the OpClear® system
Authors: Evans R, Taylor A
Published: Poster presented at RCOG 2022
Retrospective study of operating efficiency in laparoscopic hysterectomy using the OpClear® system

Clinical Data

Stop the Smudge: OpClear®, a Novel Solution to the Loss of Vision During Laparoscopic Colorectal Surgery.
23 Aug 2022
Stop the Smudge: OpClear®, a Novel Solution to the Loss of Vision During Laparoscopic Colorectal Surgery.
Authors: Ozgur I, Liska D, Valante M, Steele S, Gorgun E.
Published: Poster presented at SAGES 2022.
Stop the smudge: OpClear®, a novel solution to loss of vision during laparoscopic colorectal surgery.

Clinical Data

OpClear®: Ensuring clarity, Control & Continuity During Laparoscopic Surgery
22 Aug 2022
Title: OpClear®: Ensuring Clarity, Control & Continuity during Laparoscopic Surgery.
Authors: King T, Newell A.
Published: Poster presented at SAGES 2022.

Clinical Data

Cost of Operating Room Time is $46.04 Dollars Per Minute
22 Jul 2022

Objectives: The purpose of this study is to establish a consensus estimate of operating room cost per minute based
on currently published literature.

Design: Literature review.

Main outcome measurement: Operating room cost per unit
of time.

Results and conclusions: A Google Scholar search produced 51 articles regarding “operating room cost per minute,” of which 14 had novel estimates for OR cost per minute. The mean of these estimates was $46.04 ± $32.31. There was little consistency in methodology among the included articles, which is reflected in the large range of values.

Level of Evidence: IV; Review

Keywords: Business, management, human resources, cost,
value, and efficiency.

(J Ortho Business 2022; Volume 2, Issue 4: Pages 10-13)

View the full study here: Cost of Operating Room Time is $46.04 Dollars per Minute