Comparative Sedation Study of the MyoSure Hysteroscopic Tissue Removal System

NACompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

November 30, 2009

Primary Completion Date

July 31, 2010

Study Completion Date

July 31, 2010

Conditions
Uterine FibroidsPolyps
Interventions
DEVICE

Hysteroscopic Morcellator

The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade.When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle.

Trial Locations (5)

27713

Carolina Women's Research and Wellness Center, Durham

33431

Florida Woman Care, Boca Raton

48201

Wayne State University, Detroit

55435

Minnesota Gynecology and Surgery, Edina

85013

Phoenix Gynecology Consultants, Phoenix

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Hologic, Inc.

INDUSTRY

NCT00979342 - Comparative Sedation Study of the MyoSure Hysteroscopic Tissue Removal System | Biotech Hunter | Biotech Hunter