Trials / Completed
CompletedNCT02712398
A Prospective Trial of a Bio-absorbable Mesh in Challenging Laparoscopic Ventral or Incisional Hernia Repair
A Prospective, Multi-center Trial of a Long-term Bio-Absorbable Mesh With Sepra Technology in Challenging Laparoscopic Ventral or Incisional Hernia Repair
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- C. R. Bard · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ ST in subjects receiving laparoscopic ventral or incisional hernia repair at high risk for surgical site occurrence (SSO).
Detailed description
Subjects at high risk are defined as having 1 or more of the following co-morbid conditions: body mass index (BMI) between 30-40 kg/m2, inclusive, active smokers, chronic obstructive pulmonary disease (COPD), diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, low pre-operative serum albumin, advanced age, or renal insufficiency.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Phasix™ ST | Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable. |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2019-11-15
- Completion
- 2019-11-15
- First posted
- 2016-03-18
- Last updated
- 2021-01-08
- Results posted
- 2021-01-08
Locations
16 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02712398. Inclusion in this directory is not an endorsement.