Trials / Completed
CompletedNCT03715803
Calistar A vs. Calistar S - Comparative Cohort Retrospective Analysis of Single Incision POP Systems
Calistar A vs. Calistar S - Cohort Retrospective Analysis
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 217 (actual)
- Sponsor
- Agustin Sampietro · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of this study is to compare the initial outcomes and complication of two meshes implanted through a single incision to treat anterior and apical prolapses, Calistar A and a second-generation low weight mesh called Calistar S (Soft).
Detailed description
The main objective of this study is to compare the initial outcomes and complication of two meshes implanted through a single incision to treat anterior and apical prolapses, Calistar A and a second-generation low weight mesh called Calistar S (Soft). In such sense, objective and subjective parameters will be retrospectively tested to demonstrate the safety and effectiveness of this products. Safety will be assessed by register of complications and effectiveness will be evaluated by pelvic floor reconstruction and quality of life improvements.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Calistar A mesh to treat anterior and apical POP | Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses |
| DEVICE | Calistar S mesh to treat anterior and apical POP | Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses |
Timeline
- Start date
- 2018-10-25
- Primary completion
- 2019-08-20
- Completion
- 2019-12-30
- First posted
- 2018-10-23
- Last updated
- 2020-03-20
- Results posted
- 2020-03-20
Locations
1 site across 1 country: Argentina
Source: ClinicalTrials.gov record NCT03715803. Inclusion in this directory is not an endorsement.