Trial Outcomes & Findings for MyoSure Hysteroscopic Tissue Removal System Registry Study (NCT NCT01369758)

Results Overview

Mean percent of pathology removed, based on hysteroscopic assessment immediately following completion of the treatment procedure

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

290 participants

Primary outcome timeframe

1 hour post treatment

Results posted on

2017-09-13

Participant milestones
Measure	Intrauterine Pathology, Myomectomy Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure. 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.
Overall Study STARTED	290
Overall Study COMPLETED	290
Overall Study NOT COMPLETED	0

Withdrawal data not reported

MyoSure Hysteroscopic Tissue Removal System Registry Study

Baseline characteristics by cohort
Measure	Intrauterine Pathology, Myomectomy n=278 Participants Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure. 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	278 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	278 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	278 participants n=5 Participants

Timeframe: 1 hour post treatment

Population: 559 pathologies, 187 Fibroids and 372 polyps, were removed from 278 patients.

Mean percent of pathology removed, based on hysteroscopic assessment immediately following completion of the treatment procedure

Outcome measures
Measure	Intrauterine Pathology, Myomectomy n=278 Participants Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure. 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.
Procedure Efficacy	95.4 percent of pathology Interval 93.8 to 96.9

Timeframe: 1 hour post treatment

Percentage of subjects that achieve 100% removal of target pathology, as determined by hysteroscopic exam following the treatment procedures.

Outcome measures
Measure	Intrauterine Pathology, Myomectomy n=278 Participants Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure. 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.
Percentage of Subjects That Achieve 100% Removal of Target Pathology	74.6 percentage of participants Interval 69.5 to 79.8

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Intrauterine Pathology, Myomectomy n=278 participants at risk Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure. 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.
Reproductive system and breast disorders Cervical Trauma	1.4% 4/278 • Number of events 4
Reproductive system and breast disorders Pedal Edema Post-operative	0.36% 1/278 • Number of events 1

Hologic, Inc

Phone: 508-263-8772