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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00420264
Other study ID # ThermaChoice III
Secondary ID
Status Completed
Phase N/A
First received January 10, 2007
Last updated August 13, 2013
Start date November 2005
Est. completion date May 2009

Study information

Verified date August 2013
Source Female Pelvic Medicine & Urogynecology Institute of Michigan
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Investigational study to determine if an endometrial ablation for heavy uterine bleeding, can be tolerated in the office setting without the use of intravenous medication.


Description:

A safe and effective treatment , called endometrial ablation, has been used in a hospital setting under general anesthesia for the treatment of heavy uterine bleeding. This study will evaluate if patients would tolerate the same procedure in an office setting using local anesthetics and common pain medication. This study will include twenty patients.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date May 2009
Est. primary completion date June 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 60 Years
Eligibility Inclusion Criteria:

- Heavy uterine bleeding

Exclusion Criteria:

- Uterine or cervical cancer

- Unable to tolerate office hysteroscopy

- Uterine fibroid tumors that distort endometrial cavity

- Uterine cavity greater than 12 cm

- Patients with hyperplasia or premalignant changes of the endometrium

- Active genital or urinary tract infections

- Intrauterine device

- Pregnant or want to become pregnant

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Device:
Uterine Ablation
Uterine Ablation in the office setting to see if the procedure is tolerated w/o sedation

Locations

Country Name City State
United States Grand Valley Gynecologists, PC Grand Rapids Michigan

Sponsors (2)

Lead Sponsor Collaborator
Female Pelvic Medicine & Urogynecology Institute of Michigan Ethicon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tolerability of Uterine Ablation in the office setting 30 days No
See also
  Status Clinical Trial Phase
Completed NCT01441635 - Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids Phase 2
Active, not recruiting NCT04267562 - Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness N/A
Withdrawn NCT03325868 - Effect of Ulipristal Acetate on Bleeding Patterns and Dysmenorrhea in Women With Adenomyosis Phase 4
Completed NCT01817530 - Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF) Phase 2