Nasr Fascial Closure: A Novel Device for Fascial Closure in Laparoscopic Surgery

ClinAmygate

Status: Enrolling

Conditions: Cholecystolithiasis

Treatments: Device: Berci Fascial Closure Device; Device: Nasr fascial closure device

Study type: Interventional

Funder types: Other

Identifiers

NCT06036303

PR00C1945

Details and patient eligibility

About

The study will investigate the efficacy and safety of a new fascial closure device "Nasr Fascial Closure Device" compared to the Karl Storz Berci Fascial Closure Device 26173AM.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age > 18
• eligible for Laparoscopic cholecystectomy

Exclusion criteria

• refused to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

Nasr Fascial Closure Device

Experimental group

Treatment:

Device: Nasr fascial closure device

Berci Fascial Closure Device

Active Comparator group

Treatment:

Device: Berci Fascial Closure Device