Flexible Composite Next Generation Tissue Separating Mesh in Laparoscopic Incisional/Ventral Hernia Repair

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

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-01-31

Brief Summary

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

This is a multi-center, observational study of incisional/ventral hernia repair with NG-TSM laparoscopically. The study is not randomized and has a single treatment design assessing NG-TSM intra-operatively, its ease of use and handling characteristics.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of a New Laparoscopic Technique for Parastomal Hernia Repair With Mesh

NCT00138957

Hernia Abdominal Hernia

WITHDRAWN NA

Comparison of Self-Fixating vs Non-Fixating Hernia Mesh

NCT02062775

Inguinal Hernia

COMPLETED NA

Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair

NCT02233569

Hernia, Abdominal Hernia,Ventral

TERMINATED NA

Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh

NCT00891254

Incisional Hernia

COMPLETED PHASE1

An Efficiency/Safety Study of Surgical Tissue Glue to Treat Inguinal Hernias

NCT01669837

Inguinal Hernia

COMPLETED

Detailed Description

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

The objectives of the study are to evaluate the ease of use of NG-TSM intra-operatively in laparoscopic incisional/ventral hernia repair, and assessing early outcomes post-operatively following mesh implantation, including seroma formation, hematoma, wound complications, infections, early recurrences, adverse events, and subject comfort, as well as health economic data to include quality of life, subject satisfaction data, time of procedure, length of stay, re-hospitalization, and extended hospitalization.

Conditions

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

Incisional Hernia Ventral 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

PROSPECTIVE

Study Groups

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

NG-TSM

Patients receiving NG-TSM to repair an abdominal incisional/ventral hernia

NG-TSM

Intervention Type DEVICE

Flexible Composite Next Generation Tissue Separating Mesh

Interventions

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

NG-TSM

Flexible Composite Next Generation Tissue Separating Mesh

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ethicon Physiomesh

Eligibility Criteria

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

Inclusion Criteria

* Subject must be able to provide written informed consent
* Male or female subjects that are ≥ 18 years of age
* Female subjects must be using adequate contraception, or be surgically sterile, postmenopausal or practicing abstinence, and not planning to become pregnant
* Planned laparoscopic procedure to repair an abdominal incisional/ventral hernia that requires the addition of reinforcing or bridging material to obtain the desired surgical result

Exclusion Criteria

* Subjects with a potential growth as NGTSM will not stretch significantly
* Female subjects who are pregnant on the day of implantation
* Surgical site (mesh implantation site) that is classified as contaminated (acute, non purulent, inflamed) or dirty/infected (containing retained devitalized tissue and those that involve existing clinical infection or perforated viscera)
* Subjects who have received investigational articles less than 30 days prior to enrollment or who are currently receiving investigational products or devices
* Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No