ThermaChoice III Under Local Sedation in the Office Setting

This study is currently recruiting participants.

Verified by Grand Valley Gynecologists, P.C., January 2007

First Received: January 10, 2007 No Changes Posted

Sponsors and Collaborators:	Grand Valley Gynecologists, P.C. Ethicon, Inc.
Information provided by:	Grand Valley Gynecologists, P.C.
ClinicalTrials.gov Identifier:	NCT00420264

Purpose

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.

Condition
Heavy Uterine Bleeding

Study Type:	Observational
Study Design:	Screening, Longitudinal, Defined Population, Prospective Study
Official Title:	Feasibility of Using Gynecare Thermachoice III in the Office Setting Without Conscious Sedation

Resource links provided by NLM:

MedlinePlus related topics: Vaginal Bleeding

U.S. FDA Resources

Further study details as provided by Grand Valley Gynecologists, P.C.:

Estimated Enrollment:	20
Study Start Date:	November 2005
Estimated Study Completion Date:	June 2007

Detailed 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.

Eligibility

Ages Eligible for Study:	30 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420264

Contacts

Contact: Jason B Bennett, MD	616-774-0700	bennettjb@gvgobgyn.com
Contact: Douglas M Van Drie, MD	616-774-0700	vandriedm@gvgobgyn.com

Locations

United States, Michigan
Grand Valley Gynecologists, PC	Recruiting
Grand Rapids, Michigan, United States, 49506
Contact: Douglas M Van Drie, MD 616-774-0700 vandriedm@gvgobgyn.com
Contact: Beth V Rogers, RN 616-774-0700 rogersbv@gvgobgyn.com
Principal Investigator: Jason B Bennett, MD

Sponsors and Collaborators

Grand Valley Gynecologists, P.C.

Ethicon, Inc.

Investigators

Principal Investigator:

Jason B Bennett, MD

Grand Valley Gynecologists, PC

More Information

No publications provided

Study ID Numbers:	ThermaChoice III
Study First Received:	January 10, 2007
Last Updated:	January 10, 2007
ClinicalTrials.gov Identifier:	NCT00420264 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Genital Diseases, Female
Uterine Hemorrhage
Uterine Diseases
Hemorrhage

Additional relevant MeSH terms:

Genital Diseases, Female
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Hemorrhage

ClinicalTrials.gov processed this record on September 09, 2009