Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00891657
|Principal Investigator:||Rudy Leon De Wilde, MD||Pius Clinic|