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NCT00094536 · ClinicalTrials.gov registry record · Phase 4
Evaluation of Modified Treatment Regimens for Treatment of Heavy Menstrual Bleeding Using the HerOption® System
A Phase 4 study, sponsored by CooperSurgical.
- Completed
- Registry status
- Phase 4
- Development phase
- 82
- Enrollment target
NCT00094536 is a Phase 4 study that has completed, run by CooperSurgical. The registered enrollment target is 82 participants.
The verdict
NCT00094536, a Phase 4 study, has completed, sponsored by CooperSurgical.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 82 participants
- Enrollment target
Study Summary
The Her Option® Cryoablation Therapy System is a closed-loop cryosurgical device that is used to ablate the endometrial lining in pre-menopausal women with menorrhagia (excessive menstrual bleeding) due to benign causes. This is a non-incisional procedure, which can be performed in a physicians office with minimal sedation. Initial FDA clinical studies were conducted with a two-freeze treatment pattern consisting of a 4 minute freeze with the Cryoprobe positioned in one cornu followed by a second freeze of 6 minutes with the Cryoprobe repositioned in the contralateral cornu. Since completion of the early studies, many physicians have experimented with varying freeze patterns using longer freeze durations and/or additional freezes at the fundus and the lower uterine segment. The results, as reported in the literature, indicate that these extended freeze patterns produce significantly better results than the original regimen.
Interventions
- DEVICE Extended treatment regimen using Her Option Cryotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2004-04 |
| Est. Completion | 2009-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00094536
The ClinicalTrials.gov registry entry for NCT00094536 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CooperSurgical, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Extended treatment regimen using Her Option Cryotherapy is the first listed.
NCT00094536 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00094536 about?
NCT00094536 is a clinical study titled "Evaluation of Modified Treatment Regimens for Treatment of Heavy Menstrual Bleeding Using the HerOption® System". The Her Option® Cryoablation Therapy System is a closed-loop cryosurgical device that is used to ablate the endometrial lining in pre-menopausal women with menorrhagia (excessive menstrual bleeding) due to benign causes. This is a non-incisional procedure, which can be performed in a physicians offi...
What is the current status of trial NCT00094536?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 82 participants. The study started on 2004-04. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00094536?
The interventions under investigation include: Extended treatment regimen using Her Option Cryotherapy (DEVICE).
Who is sponsoring clinical trial NCT00094536?
This trial is sponsored by CooperSurgical, which has 2 total clinical trials registered on ClinicalTrials.gov.
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