Trials / Completed
CompletedNCT00740480
Study of the ENTact Septal Staple System for Tissue Approximation During Septoplasty
A Prospective, Non-Randomized, Limited-Use Evaluation of the ENTact Septal Staple System for Tissue Approximation During Septoplasties
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 25 (actual)
- Sponsor
- ENTrigue Surgical, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this research study is to learn more about the ENTact™ Septal Staple System device performance and to collect information to support its premarket application.
Detailed description
The ENTact™ Staple System is a device that inserts a small staple or tack to hold mucosa (moist tissues) in place instead of using stitches. The staple gradually dissolves and does not need to be removed. This clinical study will evaluate: * surgical performance of the ENTact Septal Staple System * one week post op clinical evaluation of gross tissue appearance at implantation site(s) * ENTact™ Septal Staple functionality based on maintained coaptation
Conditions
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2009-02-01
- Completion
- 2009-02-01
- First posted
- 2008-08-25
- Last updated
- 2009-08-25
- Results posted
- 2009-08-21
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00740480. Inclusion in this directory is not an endorsement.