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NCT02348112 · ClinicalTrials.gov registry record
Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence
A clinical trial, sponsored by Coloplast A/S.
- Completed
- Registry status
- 416
- Enrollment target
NCT02348112 is a clinical trial that has completed, run by Coloplast A/S. The registered enrollment target is 416 participants.
The verdict
NCT02348112 has completed, sponsored by Coloplast A/S.
- COMPLETED
- Registry status
- 416 participants
- Enrollment target
Study Summary
The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single Incision Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months.
Interventions
- DEVICE Altis Single Incision Sling
- DEVICE Transobturator or Retropubic Sling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 416 participants |
| Start Date | 2015-01 |
| Est. Completion | 2021-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02348112
The ClinicalTrials.gov registry entry for NCT02348112 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 416 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Coloplast A/S, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Altis Single Incision Sling is the first listed.
NCT02348112 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02348112 about?
NCT02348112 is a clinical study titled "Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence". The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single Incision Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months.
What is the current status of trial NCT02348112?
This trial is currently completed. The enrollment target is 416 participants. The study started on 2015-01. Estimated completion is 2021-09.
What interventions are being tested in trial NCT02348112?
The interventions under investigation include: Altis Single Incision Sling (DEVICE), Transobturator or Retropubic Sling (DEVICE).
Who is sponsoring clinical trial NCT02348112?
This trial is sponsored by Coloplast A/S, which has 21 total clinical trials registered on ClinicalTrials.gov.
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