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NCT06036303 Clinical Trial

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

Cholecystolithiasis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06036303
Other study ID # PR00C1945
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2023
Est. completion date December 15, 2023

Study information
Verified date September 2023
Source ClinAmygate
Contact Mohie El-Din M Madany, MD
Phone 01141341342
Email Mohie.madany@med.aswu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 160
Est. completion date December 15, 2023
Est. primary completion date November 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age > 18 - eligible for Laparoscopic cholecystectomy Exclusion Criteria: - refused to participate

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Nasr fascial closure device
Nasr fascial closure device is a novel device for fascial closure
• Berci Fascial Closure Device
Berci Fascial Closure Device is a known device for fascial closure

Locations
Country Name City State
Egypt Aswan University Hospital Aswan

Sponsors (2)
Lead Sponsor Collaborator
ClinAmygate Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary duration of port site closure Duration in seconds 1 day
Primary Rate of failure of port site Rate of failure to close the port site 1 day
Secondary Incidence of port site infection Incidence of infection of the port site 1 month
Secondary Incidence of port site hernia Incidence of hernia at the port site 6 weeks
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