Assessment of the Wide Field of View Provided by the SurroundScope

NCT04651270 | Unknown

• 1 other identifier: CL 0334
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laparoscopic Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Assessment of the 270 Lenses clearance contribution to the procedure.

  Day of surgery

• Assessment of the 270 Lenses clearance contribution to the procedure.

  Day of surgery

• A record of complications related to the SurroundScope

  Day of surgery up to 2 weeks after the surgical procedure

Other Outcomes (3)

• Additional measurements - timing, compared to retrospective data of matched anonymous 100 patients' data from the medical records of the hospital.

  day of surgery

• Additional measurements- Intraoperative events

  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.

  Up to two weeks

Study Arms (1)

SurroundScope

EXPERIMENTAL

For laparoscopic camera system, the SurroundScope. 270-degree angle videoscope (270Surgical, Israel) was used

Device: SurroundScope

Interventions

SurroundScope DEVICE

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.

SurroundScope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• 270Surgical: lead

Study Sites (1)

Bnai Zion Medical Center

Haifa, 31048, Israel

RECRUITING

Study Officials

• Gideon Sroka, MD

  Bnai Zion Medical Center, 47 Golomb St. Haifa, 31048, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gideon Sroka, MD

CONTACT

+97248359137; Gideon.sroka@b-zion.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: December 3, 2020
• Study Start: December 9, 2020
• Primary Completion: September 1, 2023
• Study Completion: December 30, 2023
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

IL (1)