Assessment of the Wide Field of View Provided by the SurroundScope

Laparoscopic Surgery Clinical Trial

Official title:

Assessment of the Wide Field of View Provided by the SurroundScope

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04651270
• Other study ID #: CL 0334
• Status: Recruiting
• Phase: N/A
• Start date: December 9, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2023
• Source: 270Surgical
• Contact: Gideon Sroka, MD
• Phone: +97248359137
• Email: Gideon.sroka[@]b-zion.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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".

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Laparoscopic Surgery

Intervention

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.

Locations

Country	Name	City	State
Israel	Bnai Zion Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
270Surgical

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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