Trials / Completed
CompletedNCT00891657
Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy
A Randomised, Prospective, Multi-Centre Clinical Study of SprayShield™ Adhesion Barrier System as a Barrier for the Prevention of Adhesion Formation After Laparoscopic Myomectomy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Integra LifeSciences Corporation · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is planned as a prospective, randomised, parallel, controlled, multi-centre, open label, comparative evaluation of SprayShield™ Adhesion Barrier plus good surgical technique, versus good surgical technique alone, with a blinded, third party video evaluation of adhesion formation at second look laparoscopy (SLL) following laparoscopic myomectomy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SprayShield™ | Anti-adhesion barrier |
Timeline
- Start date
- 2008-11-01
- Primary completion
- 2009-05-01
- Completion
- 2009-05-01
- First posted
- 2009-05-01
- Last updated
- 2017-09-07
- Results posted
- 2010-08-31
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00891657. Inclusion in this directory is not an endorsement.