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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: Completed Phase 4 study, sponsored by CooperSurgical.
NCT00094536 is a Phase 4 study that has completed, run by CooperSurgical. The registered enrollment target is 82 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Success is defined as a pictorial bleeding assessment chart (PBAC) score of ≤ 75 at 1-year post-treatment; a score which corresponds to normal menstruation levels.
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 |
What the finished NCT00094536 record still lists
NCT00094536 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 1 intervention - of which Extended treatment regimen using Her Option Cryotherapy is the first listed.
NCT00094536 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00094536's enrollment target sits among peer trials
82 939th of 2000 higher than 1,061 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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