Clinical trial NCT01197547: Registry Study of Genesys HTA for Treatment of Menorrhagia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menorrhagia
Keywords: Menorrhagia
Lead sponsor: Minerva Surgical, Inc.
Sponsor class: INDUSTRY
First posted: 2010-09-09
Enrollment: 1014
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Burn Rate
timeFrame: Day 1
Secondary outcomes:
measure: Technical Malfunctions
timeFrame: Day 1
measure: Serious Adverse Device Effect (SADE)
timeFrame: Day 1
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Mary Birch
state: California
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Athens
country: United States
facility: Shelnutt Obstetrics and Gynecology
state: Georgia
city: Louisville
country: United States
facility: Health South Surgecenter of Louisville
state: Kentucky
city: Southfield
country: United States
facility: Wayne State University Physician Group
state: Michigan
city: Cincinnati
country: United States
facility: Seven Hills OB GYN Associates
state: Ohio
city: Columbus
country: United States
facility: Complete Healthcare for Women
state: Ohio
city: Philadelphia
country: United States
facility: Associates in Women's Healthcare
state: Pennsylvania
city: Pottsville
country: United States
facility: Schuykill Medical Center South
state: Pennsylvania
city: Chattanooga
country: United States
facility: Chattanooga Medical Research
state: Tennessee
city: Johnson City
country: United States
facility: State of Franklin Healthcare Associates
state: Tennessee
city: Bedford
country: United States
facility: Associates in Obstetrics and Gynecology
state: Texas
city: Dallas
country: United States
facility: Central Womens Care PA
state: Texas
city: Grapevine
country: United States
facility: Doreen Moser, DO
state: Texas
city: Irving
country: United States
facility: MacArthur OBGYN
state: Texas
city: Plano
country: United States
facility: Personalized Women's Healthcare
state: Texas
city: Ogden
country: United States
facility: Ogden Clinic
state: Utah
city: Salt Lake City
country: United States
facility: Old Farm Obstetrics and Gynecology
state: Utah
city: Milwaukee
country: United States
facility: Milwaukee ObGyn
state: Wisconsin
Study officials:
affiliation: Boston Scientific Corporation
name: Thomas Bowman, M.D.
role: STUDY_DIRECTOR
References: