Clinical trial · Interventional
Symphion® System In-Office Study
A Pilot Study to Assess the Feasibility of the Symphion® Bipolar Hysteroscopic Tissue Resection System in an Office Environment
NCT02520414CI-TRIAL-00050911completedN/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 purpose of this study is to determine the safety and feasibility of using the Symphion system in an office setting.
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 |
|---|---|---|---|
| Endometrial Polyps | — | UNRESOLVED | — |
| Uterine Leiomyomas | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Symphion® Bipolar Hysteroscopic Tissue Resection System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Symphion®
- description
- Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.
- interventionNames
- Device: Symphion® Bipolar Hysteroscopic Tissue Resection System
Primary outcomes (1)
- measure
- Safety Profile of the Symphion® Bipolar Hysteroscopic Tissue Resection System When Used in the Office Setting for the Removal of Intracavitary Polyps and Myomas.
- timeFrame
- 2 weeks
- description
- Absence of device related adverse events, or death.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects must meet the approved Instructions for Use for the Symphion® bipolar hysteroscopic tissue resection system * Confirmation hysteroscopic evaluation to access appropriate pathology type and size meets the Protocol guidelines for inclusion * Subject has signed written Informed Consent Exclusion Criteria: * Subjects who are pregnant * Subjects who have an active genital tract infection (as assessed by the physician) * Subjects who have cervical malignancies * Subjects who have previously been diagnosed with endometrial cancer * Subjects who have Type 2 intracavitary myomas * Type 0 or 1 intracavitary myoma greater than 3.0 cm
References
Publications (0)
Data not yet available
No reference posted for this study.