N/A
Completed N=11
Clinical Evaluation of the Interlace Medical Hysteroscopic Morcellator
Abnormal Uterine Bleeding · Infertility
Source: ClinicalTrials.gov NCT01026805 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Dec 2009
Primary outcomePrimary: Percentage of Tissue Removed — 97.5 Percentage of tissue removed
Summary
This study assesses the effectiveness of intrauterine fibroid and polyp removal using the Interlace Medical 1st generation hysteroscopic morcellator device based on a retrospective review of medical records of women who have been treated with the device.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Tissue Removed |
97.5 | — |
| SECONDARY Treatment Time Per Patient |
4.3 | — |
| SECONDARY Fluid Volume Per Procedure |
5179.0 | — |
| SECONDARY Fluid Deficit Per Procedure |
567.8 | — |
| SECONDARY Resected Tissue Weight Per Patient |
10.8 | — |
| SECONDARY Interlace Medical 1st Generation Hysteroscopic Morcellator Cutting Ability - Mean Score |
9.5 | — |
| SECONDARY Adverse Events |
— | — |
Eligibility Criteria
Inclusion Criteria
- female
- at least 18 years old
- treated for intra-uterine submucosal fibroids (Type 0 or 1 myomas and/or polyps using the Interlace 1st generation morcellator device.
Exclusion Criteria
- none
Data sourced from ClinicalTrials.gov (NCT01026805). 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.