NCT06036303

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

September 5, 2023

Last Update Submit

September 17, 2023

Conditions

Cholecystolithiasis

Keywords

Laparoscopic removal

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • Incidence of port site infection

    1 month

  • Incidence of port site hernia

    6 weeks

Study Arms (2)

Nasr Fascial Closure Device

EXPERIMENTAL
Device: Nasr fascial closure device

Berci Fascial Closure Device

ACTIVE COMPARATOR
Device: Berci Fascial Closure Device

Interventions

Nasr fascial closure deviceDEVICE

Nasr fascial closure device is a novel device for fascial closure

Nasr Fascial Closure Device
Berci Fascial Closure DeviceDEVICE

Berci Fascial Closure Device is a known device for fascial closure

Berci Fascial Closure Device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18
  • eligible for Laparoscopic cholecystectomy

You may not qualify if:

  • refused to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University Hospital

Aswān, Egypt

RECRUITING

MeSH Terms

Conditions

Cholecystolithiasis

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Study Officials

  • Mohie El-Din M Madany

    Aswan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohie El-Din M Madany, MD

CONTACT

01141341342Mohie.madany@med.aswu.edu.eg

Emad R Issak, MSc

CONTACT

01066208065emangate@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 13, 2023

Study Start

September 15, 2023

Primary Completion

November 15, 2023

Study Completion

December 15, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations

EG(1)