Assessment of the Wide Field of View Provided by the SurroundScope

The aim of this study is to assess the need and potential benefits of the wide field of view during general and gynecology laparoscopic surgery.

Study Overview

• Status: Recruiting
• Conditions: Laparoscopic Surgery
• Intervention / Treatment: Device: SurroundScope

Detailed Description

The tremendous popularity of the laparoscopic surgeries is balanced with its tradeoffs - the needs for an excellent intracavitary visualization along with a surgeon skill set capable of performing these, often more technically challenging procedures. Image quality has improved, but there are still various restrictions to images captured by the lens at the tip of a long tubular laparoscope.

270Surgical developed a 270 degree angle scope to overcome these unmet needs and improve the image quantity and extent during laparoscopy. The study will evaluate standard laparoscopic surgery using the 270Surgical system; "The SurroundScope".

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gideon Sroka, MD; Phone Number: +97248359137; Email: Gideon.sroka@b-zion.org.il

Study Locations

• Israel
  • Haifa, Israel, 31048
    • Recruiting
    • Bnai Zion Medical Center
    • Contact: Gideon Sroka, MD; Phone Number: +972 (4) -8359137; Email: Gideon.sroka@b-zion.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age greater than or equal to 18
2. Capable of giving informed consent
3. Scheduled for general or gynecology laparoscopic surgery or open procedure that in the surgeon's opinion can be performed laparoscopically with the 270System

Exclusion Criteria:

1. Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator)
2. Patients with contraindications to undergo surgery
3. Patients with ASA class* >3
4. Advanced cirrhosis with failure of hepatic function
5. Patients who have participated in another interventional clinical study in the last month
6. Pregnancy
7. Unable to consent (due to cultural, language or neurological barriers)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SurroundScope; For laparoscopic camera system, the SurroundScope. 270-degree angle videoscope (270Surgical, Israel) was used	Device: SurroundScope; The study will evaluate standard laparoscopic surgery using the 270Surgical system. The procedure will be performed according to the institution's standard of care, using the SurroundScope for visualization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the need and potential benefits of the wide field of view	Assessed by a multi-question subjective questionnaire completed in the OR, immediately after the case, by the surgeon and the camera person and constructed on a Likert-type, 5-point scale (1=Strongly disagree, 2=Disagree, 3=Neither agree or disagree, 4=Agree, 5=Strongly agree).	Day of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the 270 Lenses clearance contribution to the procedure.	Lenses clearance contribution will be assessed by: Rating of the visual impairment due to smoke using a likert-type scale of 1-5: 1=imperceptible, 2= perceptible but not interfering, 3=same as in standard procedure, 4=annoying, 5=Very annoying.	Day of surgery
Assessment of the 270 Lenses clearance contribution to the procedure.	Lenses clearance contribution will be assessed by: Amount of removals and pauses for fog and smoke incidences using a scale of 1-5: 1=none, 2= less than in standard procedure, 3=same as in standard procedure, 4= more than in standard procedure, 5=much more than in standard procedure.	Day of surgery
A record of complications related to the SurroundScope	The SurroundScope related operative complications, that require further clinical intervention	Day of surgery up to 2 weeks after the surgical procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional measurements - timing, compared to retrospective data of matched anonymous 100 patients' data from the medical records of the hospital.	Measuring time of laparoscopic procedure (lap inserted to final lap removal)	day of surgery
Additional measurements- Intraoperative events	Measurements include collecting a log of events that could have been missed with standard scope and were captured in the side screens	day of surgery
Additional measurements - lengs of stay, compared to retrospective data of matched anonymous 100 patients' data from the medical records of the hospital.	Number of days patients stayed at the hospital following the operation	Up to two weeks

Collaborators and Investigators

• Sponsor: 270Surgical
• Investigators: Principal Investigator: Gideon Sroka, MD, Bnai Zion Medical Center, 47 Golomb St. Haifa, 31048, Israel

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2020
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CL 0334

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No