Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy
|ClinicalTrials.gov Identifier: NCT00891657|
Recruitment Status : Completed
First Posted : May 1, 2009
Results First Posted : August 31, 2010
Last Update Posted : September 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Fibroid Myoma Leiomyoma||Device: SprayShield™||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomised, Prospective, Multi-Centre Clinical Study of SprayShield™ Adhesion Barrier System as a Barrier for the Prevention of Adhesion Formation After Laparoscopic Myomectomy|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
No Intervention: Control
No adhesion barrier administered.
- Number of Sites Adherent to the Uterus [ Time Frame: 8-12 weeks post myomectomy ]The number of times an adhesion is attached to the uterus.
- Mean Severity Score of Sites Adherent to the Uterus [ Time Frame: 8-12 weeks post myomectomy ]The scoring for severity is as follows: 0=no adhesions, 1=filmy, avascular adhesions, 2=vascular and/or dense adhesions, and 3=cohesive adhesions.
- Mean Extent Score of Sites Adherent to the Uterus [ Time Frame: 8-12 weeks post myomectomy ]0 =no adhesions, 1=covering <25% of locations' total area, 2=covering 26% to 50% of locations' total area, and 3=covering >51% of locations' total area.
- Area of Sites Adherent to the Uterus (cm^2) [ Time Frame: 8-12 weeks post myomectomy ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00891657
|Principal Investigator:||Rudy Leon De Wilde, MD||Pius Clinic|