Nasr Fascial Closure: A Novel Device for Fascial Closure... | NCT06036303

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

NCT06036303

Sponsor

ClinAmygate

Status

Unknown status

Last Update Posted

Sep 21, 2023Actual

Enrollment

160Estimated

Phase

Not Applicable

Conditions

Cholecystolithiasis

Interventions

Nasr fascial closure device
Berci Fascial Closure Device

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2023Actual

Primary Completion Date

Nov 15, 2023Estimated

Completion Date

Dec 15, 2023Estimated

First Submitted Date

Sep 5, 2023

First Submission Date that Met QC Criteria

Sep 12, 2023

First Posted Date

Sep 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2023

Last Update Posted Date

Sep 21, 2023Actual

Name	Class
Aswan University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nasr Fascial Closure Device	Experimental		Device: Nasr fascial closure device
Berci Fascial Closure Device	Active Comparator		Device: Berci Fascial Closure Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nasr fascial closure device	Device	Nasr fascial closure device is a novel device for fascial closure	Nasr Fascial Closure Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
duration of port site closure	Duration in seconds	1 day
Rate of failure of port site	Rate of failure to close the port site	1 day

Secondary Outcomes

Measure	Description	Time Frame
Incidence of port site infection	Incidence of infection of the port site	1 month
Incidence of port site hernia	Incidence of hernia at the port site

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age > 18
eligible for Laparoscopic cholecystectomy

Exclusion Criteria:

refused to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohie El-Din M Madany, MD	Contact	01141341342		Mohie.madany@med.aswu.edu.eg
Emad R Issak, MSc	Contact	01066208065		emangate@gmail.com

Overall Officials

Name	Affiliation	Role
Mohie El-Din M Madany	Aswan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aswan University Hospital	Recruiting	Aswān			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D041761	Cholecystolithiasis

Ancestor Terms

ID	Term
D002769	Cholelithiasis
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D005705	Gallbladder Diseases

Browse Leaves

Not provided

Browse Branches

Not provided