Heavy Uterine BleedingNCT00420264
ThermaChoice III Under Local Sedation in the Office Setting
A study testing Uterine Ablation in people with Heavy Uterine Bleeding, run by Female Pelvic Medicine & Urogynecology Institute of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Heavy Uterine Bleeding
- What is being tested?
- Uterine Ablation
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Heavy uterine bleeding
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Grand Valley Gynecologists, PC
Grand Rapids, Michigan, 49506
About this study
Official title: Feasibility of Using Gynecare Thermachoice III in the Office Setting Without Conscious Sedation
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.
Read the 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.
- Conditions
- Heavy Uterine Bleeding
- Being tested
- Uterine Ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine AblationDevice
Uterine Ablation in the office setting to see if the procedure is tolerated w/o sedation
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of Uterine Ablation in the office setting
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startNov 2005
- Primary completionJun 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy Uterine BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Female Pelvic Medicine & Urogynecology Institute of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon, Inc.
- Investigators
- Jason B Bennett, MD, Principal investigator, Grand Valley Gynecologists, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420264
- Sponsor's protocol ID
- ThermaChoice III
- Status last verified
- Aug 2013
- First submitted
- 10 Jan 2007
- Last updated
- 14 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Using Gynecare Thermachoice III in the Office Setting Without Conscious Sedation
- ClinicalTrials.gov ID
- NCT00420264
- Acronym / sponsor ID
- ThermaChoice III
- Conditions
- Heavy Uterine Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Female Pelvic Medicine & Urogynecology Institute of MichiganUniversity, hospital or other
- Collaborators
- Ethicon, Inc.
- Study start
- Nov 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 11 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Heavy uterine bleeding
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uterine AblationUterine Ablation in the office setting to see if the procedure is tolerated w/o sedation | Device | – |
Primary outcome
Tolerability of Uterine Ablation in the office setting
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason B Bennett, MD principal investigator
Grand Valley Gynecologists, PC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uterine Ablation in people with Heavy Uterine Bleeding, run by Female Pelvic Medicine & Urogynecology Institute of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of Uterine Ablation in the office setting (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2013.