Clinical Study on the Safety of SAFIL® MESH

NCT ID: NCT04947202

Last Updated: 2022-01-24

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

COMPLETED

Total Enrollment

152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2021-11-30

Brief Summary

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

Observational, Retrospective, Multi-center Clinical Study on the Safety of SAFIL® MESH in Patients Undergoing Reinforcement of Soft Tissues After Abdominal Wall Surgery or Other Fascial Defects

Detailed Description

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

The study design is a retrospective case-note series of patients that have undergone reinforcement of soft tissues with Safil® Mesh after abdominal wall surgery or other fascial defects between the period January 2019 - November 2020

Conditions

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

Abdominal Wall Defect Ventral Hernia Abdominal Hernia Fascial Hernia

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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

Safil Mesh

Hernioplasty

Intervention Type DEVICE

Hernioplasty is the repair of the defect using mesh patches.

Interventions

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

Hernioplasty

Hernioplasty is the repair of the defect using mesh patches.

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Patients operated between January 2019 - November 2020 for abdominal wall surgery or other fascial defects and received Safil® Mesh
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

B.Braun Surgical SA

INDUSTRY

Sponsor Role collaborator

Aesculap AG

INDUSTRY

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.

Izaskun Badiola Bergara, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hospital Galdakao-Usansolo

Locations

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

Hospital Galdakao-Usansolo

Galdakao, Bizkaia, Spain

Site Status

Hospital Universitario de Salamanca

Salamanca, , Spain

Site Status

Countries

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

Spain

Other Identifiers

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

AAG-O-H-2040

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Strattice in Repair of Inguinal Hernias
NCT00681291 COMPLETED PHASE4