740480
Last Update Posted: 2009-08-25
Recruiting has ended
All Genders accepted | 18 Years-65 Years |
25 Estimated Participants | No Expanded Access |
Observational Study | Accepts healthy volunteers |
Study of the ENTact Septal Staple System for Tissue Approximation During Septoplasty
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.
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
Eligibility
Relevant conditions:
Nasal Septum
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov