N/A
Completed N=10
Symphion® System In-Office Study
Source: ClinicalTrials.gov NCT02520414 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Safety Profile of the Symphion® Bipolar Hysteroscopic Tissue Resection System When Used in the Office Setting for the Removal of Intracavitary Polyps and Myomas. — 0; 0 percentage of participants
Summary
The purpose of this study is to determine the safety and feasibility of using the Symphion system in an office setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Profile of the Symphion® Bipolar Hysteroscopic Tissue Resection System When Used in the Office Setting for the Removal of Intracavitary Polyps and Myomas. |
0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02520414). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.