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

Primary Purpose

Cholecystolithiasis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Nasr fascial closure device
Berci Fascial Closure Device
Sponsored by
ClinAmygate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystolithiasis focused on measuring Laparoscopic removal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age > 18 eligible for Laparoscopic cholecystectomy Exclusion Criteria: refused to participate

Sites / Locations

  • Aswan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nasr Fascial Closure Device

Berci Fascial Closure Device

Arm Description

Outcomes

Primary Outcome Measures

duration of port site closure
Duration in seconds
Rate of failure of port site
Rate of failure to close the port site

Secondary Outcome Measures

Incidence of port site infection
Incidence of infection of the port site
Incidence of port site hernia
Incidence of hernia at the port site

Full Information

First Posted
September 5, 2023
Last Updated
September 17, 2023
Sponsor
ClinAmygate
Collaborators
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06036303
Brief Title
Nasr Fascial Closure: A Novel Device for Fascial Closure in Laparoscopic Surgery
Official Title
Nasr Fascial Closure: A Novel Device for Fascial Closure in Laparoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ClinAmygate
Collaborators
Aswan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystolithiasis
Keywords
Laparoscopic removal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nasr Fascial Closure Device
Arm Type
Experimental
Arm Title
Berci Fascial Closure Device
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Nasr fascial closure device
Intervention Description
Nasr fascial closure device is a novel device for fascial closure
Intervention Type
Device
Intervention Name(s)
Berci Fascial Closure Device
Intervention Description
Berci Fascial Closure Device is a known device for fascial closure
Primary Outcome Measure Information:
Title
duration of port site closure
Description
Duration in seconds
Time Frame
1 day
Title
Rate of failure of port site
Description
Rate of failure to close the port site
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Incidence of port site infection
Description
Incidence of infection of the port site
Time Frame
1 month
Title
Incidence of port site hernia
Description
Incidence of hernia at the port site
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age > 18 eligible for Laparoscopic cholecystectomy Exclusion Criteria: refused to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohie El-Din M Madany, MD
Phone
01141341342
Email
Mohie.madany@med.aswu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Emad R Issak, MSc
Phone
01066208065
Email
emangate@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohie El-Din M Madany
Organizational Affiliation
Aswan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aswan University Hospital
City
Aswan
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohie El-Din M Madany, MD
Phone
01141341342
Email
Mohie.madany@med.aswu.edu.eg
First Name & Middle Initial & Last Name & Degree
Mohie El-Din M Madany, MD

12. IPD Sharing Statement

Learn more about this trial

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

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