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RecruitingNCT06036303Updated Sep 21, 2023

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

An interventional study of Nasr fascial closure device and Berci Fascial Closure Device in Cholecystolithiasis, sponsored by ClinAmygate. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by ClinAmygate · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cholecystolithiasis

Keywords

  • Laparoscopic removal
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • age > 18
  • eligible for Laparoscopic cholecystectomy

Exclusion criteria

Exclusion Criteria:

  • refused to participate
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    Nasr Fascial Closure Device

    Device: Nasr fascial closure device

  • Active comparator
    Berci Fascial Closure Device

    Device: Berci Fascial Closure Device

Interventions

  • DeviceNasr fascial closure device

    Nasr fascial closure device is a novel device for fascial closure

  • DeviceBerci Fascial Closure Device

    Berci Fascial Closure Device is a known device for fascial closure

05

What researchers measure

Primary outcomes

  1. duration of port site closure

    Duration in seconds

    Time frame: 1 day

  2. Rate of failure of port site

    Rate of failure to close the port site

    Time frame: 1 day

Secondary outcomes

  1. Incidence of port site infection

    Incidence of infection of the port site

    Time frame: 1 month

  2. Incidence of port site hernia

    Incidence of hernia at the port site

    Time frame: 6 weeks

06

Study locations

1 of 1 sites recruiting
  • Aswan University Hospital
    Aswan, Egypt
    Recruiting
07

Registry details

Key details

Study ID
NCT06036303
Lead sponsor
ClinAmygate
Collaborators
Aswan University Hospital
Responsible party
Sponsor
First posted
Sep 13, 2023
Start date
Sep 15, 2023
Primary completion
Nov 15, 2023 (estimated)
Completion
Dec 15, 2023 (estimated)
Last update
Sep 21, 2023

Study contacts

Mohie El-Din M Madany, MD
Contact
Mohie.madany@med.aswu.edu.eg
01141341342
Emad R Issak, MSc
Contact
emangate@gmail.com
01066208065
Mohie El-Din M Madany
principal investigator · Aswan University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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