Menorrhagia
Conditions
Keywords
Menorrhagia
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.
Interventions
DEVICEGenesys HTA
Genesys HTA Endometrial Ablation
Sponsors
Minerva Surgical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Burn Rate | Day 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Genesys HTA Genesys HTA Endometrial Ablation
Genesys HTA: Genesys HTA Endometrial Ablation | 1,014 |
| Total | 1,014 |
Baseline characteristics
| Characteristic | Genesys HTA |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1013 Participants |
| Age, Continuous | 41 years STANDARD_DEVIATION 6.8 |
| Region of Enrollment United States | 1014 participants |
| Sex: Female, Male Female | 1014 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 992 |
| serious Total, serious adverse events | 1 / 992 |
Outcome results
Primary
Burn Rate
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Genesys HTA | Burn Rate | 4 participants |
Secondary
Serious Adverse Device Effect (SADE)
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
Population: 992 - Intent-To-Treat (ITT) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genesys HTA | Serious Adverse Device Effect (SADE) | Subjects with at least one Serious adverse event | 1 number of participants |
| Genesys HTA | Serious Adverse Device Effect (SADE) | Injury, poisoning and procedural complications | 1 number of participants |
| Genesys HTA | Serious Adverse Device Effect (SADE) | Thermal burn | 1 number of participants |
Secondary
Technical Malfunctions
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
Population: 992 patients = ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Genesys HTA | Technical Malfunctions | complaint - procedure stopped to prevent injury | .6 percent of participants |
| Genesys HTA | Technical Malfunctions | Subjects with At Least One Technical Complaint | 4.4 percent of participants |
| Genesys HTA | Technical Malfunctions | Subjects with One Technical Complaint | 3.5 percent of participants |
| Genesys HTA | Technical Malfunctions | Subjects with Two Technical Complaints | .9 percent of participants |
| Genesys HTA | Technical Malfunctions | Subjects with Three Technical Complaints | 0.0 percent of participants |
| Genesys HTA | Technical Malfunctions | Subjects with More Than Three Technical Complaints | 0.0 percent of participants |
| Genesys HTA | Technical Malfunctions | Subjects with 1+ Component with Tech Comp | 4.4 percent of participants |
| Genesys HTA | Technical Malfunctions | Subjects with One Component with Technical Complai | 4.2 percent of participants |
| Genesys HTA | Technical Malfunctions | Subjects with Two Component with Technical Complai | .2 percent of participants |