---
title: Clinical Evaluation of the Interlace Medical Hysteroscopic Morcellator
nct_id: NCT01026805
overall_status: COMPLETED
sponsor: Hologic, Inc.
study_type: OBSERVATIONAL
primary_condition: Abnormal Uterine Bleeding
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01026805.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01026805"
ct_last_update_post_date: 2012-11-22
last_seen_at: "2026-05-12T07:07:06.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Clinical Evaluation of the Interlace Medical Hysteroscopic Morcellator

**Official Title:** Retrospective Case Review - Clinical Evaluation of the Interlace Medical 1st Generation Hysteroscopic Morcellator

**NCT ID:** [NCT01026805](https://clinicaltrials.gov/study/NCT01026805)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 11
- **Lead Sponsor:** Hologic, Inc.
- **Conditions:** Abnormal Uterine Bleeding, Infertility
- **Start Date:** 2009-02
- **Completion Date:** 2009-03
- **CT.gov Last Update:** 2012-11-22

## Brief 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.

## Detailed Description

A retrospective review of medical records for eleven (11) premenopausal women who had been treated with the new hysteroscopic morcellator was conducted at four hospital or ambulatory surgical center sites. Four physicians performed hysteroscopic operative procedures to remove intrauterine polyps, type 0 (completely within the uterine cavity), type I (mostly within the cavity) and type II (\< 40% within the cavity) submucous myomas. Percent pathology removed, total morcellation time, total fluid used, fluid deficit and treatment-related adverse events were assessed. Each of the four treating physicians also evaluated device performance using a 10 point scale (1 = "poor" and 10 = "excellent").

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Hysteroscopic Morcellator** — 11 women previously receiving hysteroscopic myomectomy or polypectomy using the hysteroscopic morcellator device.

## Interventions

- **Interlace Medical 1st Generation Hysteroscopic Morcellator** (DEVICE) — The Interlace Medical hysteroscopic morcellator system has been cleared by the FDA(K073690)and consists of a motor drive unit connected to a 3mm morcellator. The morcellator is approximately 12 cm long and is equipped with an open channel that houses a reciprocating blade. When the motor is activated, the reciprocating blade will cut the tissue within the channel. The tissue travels down the 3mm morcellator shaft cannula via suction coupled to the proximal end of the morcellator and is captured in a tissue trap in a suction canister for pathological diagnosis following the procedure.

## Primary Outcomes

- **Percentage of Tissue Removed** _(time frame: immediately post-treatment)_ — mean percentage of polyp and fibroid tissue removed, as measured on post-treatment hysteroscopic imaging. Images were obtained immediately post treatment, before the subject left the surgical suite.

## Secondary Outcomes

- **Treatment Time Per Patient** _(time frame: at time of treatment)_
- **Fluid Volume Per Procedure** _(time frame: at time of treatment)_
- **Fluid Deficit Per Procedure** _(time frame: at time of treatment)_
- **Resected Tissue Weight Per Patient** _(time frame: at time of treatment)_
- **Interlace Medical 1st Generation Hysteroscopic Morcellator Cutting Ability - Mean Score** _(time frame: 2-3 months post treatment)_
- **Adverse Events** _(time frame: 2-3 months post-treatment)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01026805.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01026805*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*