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NCT01261988 · ClinicalTrials.gov registry record · Phase 1
Assess the Safety and Adhesive Performance of the VIPER System When Compared to Esteem™
A Phase 1 study of Ostomy, sponsored by ConvaTec.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT01261988: Completed Phase 1 study of Ostomy, sponsored by ConvaTec.
NCT01261988 is a Phase 1 study of Ostomy that has completed, run by ConvaTec. The registered enrollment target is 10 participants, below the 899-participant average among 6 other Ostomy trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01261988, a Phase 1 study of Ostomy, has completed, sponsored by ConvaTec.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of the study is to assess the safety and adhesive performance of the VIPER System when compared to the Esteem™ Cut to Fit One Piece Closed End Pouch when used by healthy volunteers.
Primary Outcome
All adverse events (AE's) related to the use of the device
Conditions Studied
Interventions
- DEVICE VIPER
- DEVICE Esteem™ Cut to Fit One Piece Closed End Pouch
Study Locations (1)
New Jersey
- Susan Bell, RN, MSN, CWOCN - Jobstown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2010-12 |
| Est. Completion | 2010-12 |
| Phase | Phase 1 |
What the finished NCT01261988 record still lists
NCT01261988 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 899-participant average among 6 other Ostomy trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Ostomy appearing as the primary indexed condition, and to 2 interventions - of which VIPER is the first listed.
NCT01261988 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT01261988 about?
NCT01261988 is a clinical study titled "Assess the Safety and Adhesive Performance of the VIPER System When Compared to Esteem™". The primary objective of the study is to assess the safety and adhesive performance of the VIPER System when compared to the Esteem™ Cut to Fit One Piece Closed End Pouch when used by healthy volunteers.
What is the current status of trial NCT01261988?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2010-12. Estimated completion is 2010-12.
What conditions does trial NCT01261988 study?
This clinical trial studies the following conditions: Ostomy.
What interventions are being tested in trial NCT01261988?
The interventions under investigation include: VIPER (DEVICE), Esteem™ Cut to Fit One Piece Closed End Pouch (DEVICE).
Who is sponsoring clinical trial NCT01261988?
This trial is sponsored by ConvaTec, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01261988 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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