Clinical trial · Interventional
MyoSure Hysteroscopic Tissue Removal System Registry Study
NCT01369758CI-TRIAL-00029513completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this study is to demonstrate the safety and effectiveness of community gynecologist initiated treatment of intra-uterine polyps and submucosal fibroids with the MyoSure Hysteroscopic Tissue Removal System in a significantly sized patient population.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polyps | — | UNRESOLVED | — |
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MyoSure Tissue Removal System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intrauterine pathology, myomectomy
- description
- Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure.
- interventionNames
- Device: MyoSure Tissue Removal System
Primary outcomes (1)
- measure
- Procedure Efficacy
- timeFrame
- 1 hour post treatment
- description
- Mean percent of pathology removed, based on hysteroscopic assessment immediately following completion of the treatment procedure
Secondary outcomes (1)
- measure
- Percentage of Subjects That Achieve 100% Removal of Target Pathology
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Healthy female between 18 and 65 years of age 2. Subject must be able to understand, read and sign the study specific informed consent forms after the nature of the study has been fully explained to her 3. Subject is indicated for myomectomy or polypectomy 4. Subject exhibits intrauterine polyps and/or submucous myomas which meet one of the following criteria. In cases of subjects with multiple intrauterine pathology, classification is based as follows: * All polyps * All Type 0, Type 1 or Type 2 myomas ≤ 6 cm in diameter * Polyps plus Type 0, Type 1 or Type 2 myomas ≤6 cm in diameter Exclusion Criteria: 1. Subject is pregnant 2. Subject has an Intrauterine Device (IUD) at the time of the procedure. A subject may be enrolled in the study if the IUD is removed prior to the treatment procedure 3. Subject is taking an anticoagulant or antiplatelet medication other than low dose aspirin 4. Active pelvic inflammatory disease or pelvic/vaginal infection 5. Subject has a known or suspected coagulopathy or bleeding disorder 6. Subject has a history of disease which increases the risk for fluid overload (i.e. significant cardiac, hepatic, or renal dysfunction) 7. Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study
References
Publications (0)
Data not yet available
No reference posted for this study.