Trial Outcomes & Findings for Registry Study of Genesys HTA for Treatment of Menorrhagia (NCT NCT01197547)

NCT ID: NCT01197547

Last Updated: 2021-03-26

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1014 participants
• Primary outcome timeframe: Day 1
• Results posted on: 2021-03-26

Participant Flow

Participant milestones

Measure	Genesys HTA Genesys HTA Endometrial Ablation
Overall Study STARTED	1014
Overall Study COMPLETED	992
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Registry Study of Genesys HTA for Treatment of Menorrhagia

Baseline characteristics by cohort

Measure	Genesys HTA n=1014 Participants Genesys HTA Endometrial Ablation Genesys HTA: Genesys HTA Endometrial Ablation
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1013 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	41 years STANDARD_DEVIATION 6.8 • n=5 Participants
Sex: Female, Male Female	1014 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	1014 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Outcome measures

Measure	Genesys HTA n=992 Participants Genesys HTA Endometrial Ablation
Burn Rate	4 participants

SECONDARY outcome

Timeframe: Day 1

Population: 992 patients = ITT population

A secondary endpoint of the Genesys HTA Post Approval Study is to assess technical complaints (i.e. disposable and hardware issues). Technical complaints are issues related to system components encountered during the procedure such as error messages, problems with the connection, power, early incomplete procedure terminations, or display/user interface, or damage to the unit.

Outcome measures

Measure	Genesys HTA n=992 Participants Genesys HTA Endometrial Ablation
Technical Malfunctions complaint - procedure stopped to prevent injury	.6 percent of participants Interval 0.2 to 1.3
Technical Malfunctions Subjects with At Least One Technical Complaint	4.4 percent of participants Interval 3.2 to 5.9
Technical Malfunctions Subjects with One Technical Complaint	3.5 percent of participants Interval 2.5 to 4.9
Technical Malfunctions Subjects with Two Technical Complaints	.9 percent of participants Interval 0.4 to 1.7
Technical Malfunctions Subjects with Three Technical Complaints	0.0 percent of participants Interval 0.0 to 0.4
Technical Malfunctions Subjects with More Than Three Technical Complaints	0.0 percent of participants Interval 0.0 to 0.4
Technical Malfunctions Subjects with 1+ Component with Tech Comp	4.4 percent of participants Interval 3.2 to 5.9
Technical Malfunctions Subjects with One Component with Technical Complai	4.2 percent of participants Interval 3.1 to 5.7
Technical Malfunctions Subjects with Two Component with Technical Complai	.2 percent of participants Interval 0.0 to 0.7

SECONDARY outcome

Timeframe: Day 1

Population: 992 - Intent-To-Treat (ITT) population

A secondary endpoint of the Genesys HTA Post Approval Study is to assess Serious Adverse Device Effects. Per the approved protocol, an SADE is an adverse device effect resulting in any of the consequences characteristic of a serious adverse event, or that might have led to any of these consequences if suitable action had not been taken or intervention had not been made, or if circumstances had been less opportune.

Outcome measures

Measure	Genesys HTA n=992 Participants Genesys HTA Endometrial Ablation
Serious Adverse Device Effect (SADE) Subjects with at least one Serious adverse event	1 number of participants
Serious Adverse Device Effect (SADE) Injury, poisoning and procedural complications	1 number of participants
Serious Adverse Device Effect (SADE) Thermal burn	1 number of participants

Adverse Events

Genesys HTA

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Genesys HTA n=992 participants at risk Genesys HTA Endometrial Ablation
Reproductive system and breast disorders Burn	0.10% 1/992 • Number of events 1

Other adverse events

Measure	Genesys HTA n=992 participants at risk Genesys HTA Endometrial Ablation
Reproductive system and breast disorders Clinically Non-Significant Burn	0.30% 3/992 • Number of events 3

Additional Information

Meaghan Wilk

Boston Scientific

Phone: 5086834113

Email: wilkm@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place