Assessment of the Wide Field of View Provided by the SurroundScope

NCT ID: NCT04651270

Last Updated: 2023-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-09

Study Completion Date

2023-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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".

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Laparoscopic Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SurroundScope

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

Group Type EXPERIMENTAL

SurroundScope

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

270Surgical

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gideon Sroka, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bnai Zion Medical Center

Haifa, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gideon Sroka, MD

Role: CONTACT

+97248359137 ext. 0

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Gideon Sroka, MD

Role: primary

+972 (4) -8359137

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CL 0334

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.