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

NCT ID: NCT06036303

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2023-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cholecystolithiasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nasr Fascial Closure Device

Group Type EXPERIMENTAL

Nasr fascial closure device

Intervention Type DEVICE

Nasr fascial closure device is a novel device for fascial closure

Berci Fascial Closure Device

Group Type ACTIVE_COMPARATOR

Berci Fascial Closure Device

Intervention Type DEVICE

Berci Fascial Closure Device is a known device for fascial closure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nasr fascial closure device

Nasr fascial closure device is a novel device for fascial closure

Intervention Type DEVICE

Berci Fascial Closure Device

Berci Fascial Closure Device is a known device for fascial closure

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age \> 18
* eligible for Laparoscopic cholecystectomy

Exclusion Criteria

* refused to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aswan University Hospital

OTHER

Sponsor Role collaborator

ClinAmygate

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mohie El-Din M Madany

Role: PRINCIPAL_INVESTIGATOR

Aswan University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aswan University Hospital

Aswān, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohie El-Din M Madany, MD

Role: CONTACT

01141341342

Emad R Issak, MSc

Role: CONTACT

01066208065

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mohie El-Din M Madany, MD

Role: primary

01141341342

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PR00C1945

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.