Trials / Completed
CompletedNCT01541748
Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 74 (actual)
- Sponsor
- Coloplast A/S · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This study is a prospective, single arm, multi-center, post-market study to evaluate the efficacy of Axis™ Allograft Dermis used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair.
Detailed description
The study population will be adult female patients with pelvic organ prolapse, POP-Q Stage ≥ 2 that are clinically indicated for surgical intervention with Axis Allograft Dermis in the anterior, posterior or combined (anterior and posterior) compartments.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Axis | Coloplast's Axis™ Allograft Dermis is used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair. |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2018-11-11
- Completion
- 2018-11-11
- First posted
- 2012-03-01
- Last updated
- 2020-06-30
- Results posted
- 2020-06-18
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01541748. Inclusion in this directory is not an endorsement.