ThermaChoice III Under Local Sedation in the Office Setting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heavy Uterine Bleeding

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Uterine Ablation

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Female Pelvic Medicine & Urogynecology Institute of Michigan

Principal Investigators

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Jason B Bennett, MD

Role: PRINCIPAL_INVESTIGATOR

Grand Valley Gynecologists, PC

Locations

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Grand Valley Gynecologists, PC

Grand Rapids, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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