ThermaChoice III Under Local Sedation in the Office Setting

• Sponsor: Female Pelvic Medicine & Urogynecology Institute of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT00420264
• Collaborator: Ethicon, Inc. (Industry)
• Enrollment: 21
• Location: 1
• Duration (Months): 42
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Heavy Uterine Bleeding	Device: Uterine Ablation	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Feasibility of Using Gynecare Thermachoice III in the Office Setting Without Conscious Sedation
• Study Start Date: Nov 1, 2005
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: May 1, 2009

Outcome Measures

Primary Outcome Measures

1. Tolerability of Uterine Ablation in the office setting [30 days]

Eligibility Criteria

Criteria

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

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

Locations

	Site	City	State	Country	Postal Code
1	Grand Valley Gynecologists, PC	Grand Rapids	Michigan	United States	49506

Sponsors and Collaborators

• Female Pelvic Medicine & Urogynecology Institute of Michigan
• Ethicon, Inc.

Investigators

• Principal Investigator: Jason B Bennett, MD, Grand Valley Gynecologists, PC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00420264
• Other Study ID Numbers: ThermaChoice III
• First Posted: Jan 11, 2007
• Last Update Posted: Aug 14, 2013
• Last Verified: Aug 1, 2013

• Additional relevant MeSH terms: Uterine Hemorrhage

Study Results

No Results Posted as of Aug 14, 2013