Assessment of the Wide Field of View Provided by the SurroundScope

270Surgical

Status: Enrolling

Conditions: Laparoscopic Surgery

Treatments: Device: SurroundScope

Study type: Interventional

Funder types: Industry

Identifiers

NCT04651270

CL 0334

Details and patient eligibility

About

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.

Full 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".

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

SurroundScope

Experimental group

Description:

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

Treatment:

Device: SurroundScope