Trials / Completed
CompletedNCT03495154
Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair
A Multi-center Post-market Single Arm Prospective Study of Parietene™ DS Composite Mesh in Subjects Undergoing Ventral Hernia Repair
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 145 (actual)
- Sponsor
- Medtronic - MITG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A multi-center post-market single arm prospective study of Parietene™ DS Composite Mesh in subjects undergoing ventral hernia repair to confirm its clinical safety and performance in the short (1, 3 months), mid (12 months) and long term (24 months)
Detailed description
A multi-center post-market single arm prospective study of Parietene™ DS Composite Mesh in subjects undergoing ventral hernia repair to confirm its clinical safety and performance in the short (1, 3 months), mid (12 months) and long term (24 months) 125 male or female adults subjects will be enrolled in a minimum of 4 USA sites who are undergoing elective ventral hernia repair (primary or incisional)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Parietene DS Composite Mesh | All subjects enrolled will receive the Parietene DS Composite Mesh |
Timeline
- Start date
- 2018-06-21
- Primary completion
- 2021-07-21
- Completion
- 2022-07-06
- First posted
- 2018-04-11
- Last updated
- 2024-04-23
- Results posted
- 2022-11-17
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03495154. Inclusion in this directory is not an endorsement.