ThermaChoice III Under Local Sedation in the Office Setting

Heavy Uterine Bleeding Clinical Trial

Official title:

Feasibility of Using Gynecare Thermachoice III in the Office Setting Without Conscious Sedation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00420264
• Other study ID #: ThermaChoice III
• 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

• Heavy Uterine Bleeding
• Uterine Hemorrhage

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