Skip to main content
OpenTrials
Completed

NCT Number: NCT00420264

ThermaChoice III Under Local Sedation in the Office Setting

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heavy Uterine Bleeding

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Grand Valley Gynecologists, PC

Grand Rapids, Michigan, 49506, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Uterine Ablation

Device

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

Primary outcomes

  1. Tolerability of Uterine Ablation in the office setting

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Female Pelvic Medicine & Urogynecology Institute of Michigan

Other

Collaborators

  • Ethicon, Inc.

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Jan 11, 2007
Registry last updated
Aug 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.