Registry Study of Genesys HTA for Treatment of Menorrhagia

• Sponsor: Minerva Surgical, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01197547
• Collaborator: (none)
• Enrollment: 1,014
• Locations: 19
• Arm: 1
• Duration (Months): 21
• Patients Per Site: 53.4
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

This is a clinical registry of an FDA approved device system called the Genesys Hydro ThermAblatorTM (HTA) system (Boston Scientific). The HTA system's intended use is to be inserted, by a trained physician, into the uterus, where it will fill and circulate fluid that is warm enough to change the characteristics of the uterine lining. This is done with the anticipated result of improving menstrual bleeding symptoms.

The purpose of this FDA-mandated registry is to obtain clinical experience on the use the Genesys HTA™ system, under normal clinical conditions, and document its safety and technical reliability.

Condition or Disease	Intervention/Treatment	Phase
Menorrhagia	Device: Genesys HTA	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1014 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Genesys HTA Post Approval Registry A Multi-center, Single-arm, Prospective Registry of the Genesys HTA System for the Treatment of Menorrhagia
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Genesys HTA Genesys HTA Endometrial Ablation	Device: Genesys HTA; Genesys HTA Endometrial Ablation; Other Names: Genesys HTA Endometrial Ablation

Outcome Measures

Primary Outcome Measures

1. Burn Rate [Day 1]

Secondary Outcome Measures

1. Technical Malfunctions [Day 1]

   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.

2. Serious Adverse Device Effect (SADE) [Day 1]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject must meet the approved indication for use to be considered for this registry.

Exclusion Criteria:

• All subjects contraindicated for the treatment of the Genesys HTA System per the

Directions for Use will be excluded:

1. The subject is pregnant or wants to be pregnant in the future

2. The subject has known or suspected endometrial carcinoma or premalignant change of the endometrium, such as adenomatous hyperplasia

3. The subject has active pelvic inflammatory disease or pyosalpinx

4. The subject has hydrosalpinx

5. The subject in whom a tight cervical seal cannot be established and maintained around the procedure sheath

6. The subject has an anatomical condition (e.g. history of previous classical cesarean section or transmural myomectomy) or pathologic condition (e.g. long term medical therapy) that could lead to weakening of the myometrium

7. The subject has an intrauterine device in place

8. The subject has an active genital or urinary tract infection (e.g. cervicitis, endometritis, vaginitis, cystitis, etc.) at the time of treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sharp Mary Birch	San Diego	California	United States	92123
2	Christiana Hospital	Newark	Delaware	United States	19718
3	Shelnutt Obstetrics and Gynecology	Athens	Georgia	United States	30606
4	Health South Surgecenter of Louisville	Louisville	Kentucky	United States	40207
5	Wayne State University Physician Group	Southfield	Michigan	United States	48034
6	Seven Hills OB GYN Associates	Cincinnati	Ohio	United States	45201
7	Complete Healthcare for Women	Columbus	Ohio	United States	43213
8	Associates in Women's Healthcare	Philadelphia	Pennsylvania	United States	19115
9	Schuykill Medical Center South	Pottsville	Pennsylvania	United States	17901
10	Chattanooga Medical Research	Chattanooga	Tennessee	United States	37404
11	State of Franklin Healthcare Associates	Johnson City	Tennessee	United States	37604
12	Associates in Obstetrics and Gynecology	Bedford	Texas	United States	76021
13	Central Womens Care PA	Dallas	Texas	United States	75231
14	Doreen Moser, DO	Grapevine	Texas	United States	76051
15	MacArthur OBGYN	Irving	Texas	United States	75062
16	Personalized Women's Healthcare	Plano	Texas	United States	75093
17	Ogden Clinic	Ogden	Utah	United States	84403
18	Old Farm Obstetrics and Gynecology	Salt Lake City	Utah	United States	84107
19	Milwaukee ObGyn	Milwaukee	Wisconsin	United States	53221

Sponsors and Collaborators

• Minerva Surgical, Inc.

Investigators

• Study Director: Thomas Bowman, M.D., Boston Scientific Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Minerva Surgical, Inc.
• ClinicalTrials.gov Identifier: NCT01197547
• Other Study ID Numbers: U8088
• First Posted: Sep 9, 2010
• Last Update Posted: Mar 26, 2021
• Last Verified: Apr 1, 2017

• Keywords provided by Minerva Surgical, Inc.: Menorrhagia
• Additional relevant MeSH terms: Menorrhagia

Study Results

Participant Flow

Arm/Group Title	Genesys HTA
Arm/Group Description	Genesys HTA Endometrial Ablation
Period Title: Overall Study
STARTED	1014
COMPLETED	992
NOT COMPLETED	22

Baseline Characteristics

Arm/Group Title	Genesys HTA
Arm/Group Description	Genesys HTA Endometrial Ablation Genesys HTA: Genesys HTA Endometrial Ablation
Overall Participants	1014
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1013 99.9%
>=65 years	1 0.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41 (6.8)
Sex: Female, Male (Count of Participants)
Female	1014 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	1014 100%

Outcome Measures

1. Primary Outcome

Title	Burn Rate
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Genesys HTA
Arm/Group Description	Genesys HTA Endometrial Ablation
Measure Participants	992
Number [participants]	4 0.4%

2. Secondary Outcome

Title	Technical Malfunctions
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

992 patients = ITT population

Arm/Group Title	Genesys HTA
Arm/Group Description	Genesys HTA Endometrial Ablation
Measure Participants	992
complaint - procedure stopped to prevent injury	.6 0.1%
Subjects with At Least One Technical Complaint	4.4 0.4%
Subjects with One Technical Complaint	3.5 0.3%
Subjects with Two Technical Complaints	.9 0.1%
Subjects with Three Technical Complaints	0.0 0%
Subjects with More Than Three Technical Complaints	0.0 0%
Subjects with 1+ Component with Tech Comp	4.4 0.4%
Subjects with One Component with Technical Complai	4.2 0.4%
Subjects with Two Component with Technical Complai	.2 0%

3. Secondary Outcome

Title	Serious Adverse Device Effect (SADE)
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

992 - Intent-To-Treat (ITT) population

Arm/Group Title	Genesys HTA
Arm/Group Description	Genesys HTA Endometrial Ablation
Measure Participants	992
Subjects with at least one Serious adverse event	1 0.1%
Injury, poisoning and procedural complications	1 0.1%
Thermal burn	1 0.1%

Adverse Events

Arm/Group Title	Genesys HTA
Arm/Group Description	Genesys HTA Endometrial Ablation
All Cause Mortality
	Genesys HTA
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Genesys HTA
	Affected / at Risk (%)	# Events
Total	1/992 (0.1%)
Reproductive system and breast disorders
Burn	1/992 (0.1%)	1
Other (Not Including Serious) Adverse Events
	Genesys HTA
	Affected / at Risk (%)	# Events
Total	3/992 (0.3%)
Reproductive system and breast disorders
Clinically Non-Significant Burn	3/992 (0.3%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.