NCT01369758

MyoSure Hysteroscopic Tissue Removal System Registry Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 290 (actual)
• Sponsor: Hologic, Inc. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to demonstrate the safety and effectiveness of community gynecologist initiated treatment of intra-uterine polyps and submucosal fibroids with the MyoSure Hysteroscopic Tissue Removal System in a significantly sized patient population.

Detailed description

Between 500 and 600 subjects will be enrolled in a prospective, multi-center registry study. Approximately 100 of these cases will be completed in an office setting, with the remaining 400-500 cases completed in a hospital outpatient or ambulatory surgery center. Subjects will undergo a hysteroscopic tissue removal procedure to remove intrauterine polyps and submucosal fibroids.

Conditions

• Uterine Fibroids
• Polyps

Interventions

Type	Name	Description
DEVICE	MyoSure Tissue Removal System	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.

Timeline

• Start date: 2010-11-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2011-06-09
• Last updated: 2017-09-13
• Results posted: 2017-09-13

Locations

1 site across 1 country: United States