Interlace Medical Comparative Sedation Study
Forty subjects will be enrolled in a randomized, controlled study conducted at four
physician offices or day surgery settings. Subjects will be randomized 1:1 to a local
anesthetic group (Group #1 or Group #2). Subjects will undergo a hysteroscopic tissue
removal procedure to remove intrauterine polyps, type 0 fibroids, or type I fibroids.
Subsequent to the procedure, subjects will be randomized 1:1 within the local anesthetic
group to a post procedure pain management group (Group A or Group B). Subject self-reported
pain scores (as rated on an 11 point scale)will be compared at three time points:
Immediately post procedure, prior to discharge from the treatment facility, and at 48 hours
post procedure.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Subject tolerance of procedure-related pain rated on an 11 point scale (0-10)
Immediately post treatment
No
Andrea Lukes, MD
Principal Investigator
Carolina Women's Research and Wellness Center
United States: Institutional Review Board
TMP 200902
NCT00979342
November 2009
July 2010
Name | Location |
---|---|
Wayne State University | Detroit, Michigan 48202 |
Minnesota Gynecology and Surgery | Edina, Minnesota 55435 |
Phoenix Gynecology Consultants | Phoenix, Arizona 85013 |
Florida Woman Care | Boca Raton, Florida 33431 |
Carolina Women's Research and Wellness Center | Durham, North Carolina 27713 |