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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01369758
Other study ID # TMP 200905
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received November 11, 2010
Last updated November 20, 2012
Start date November 2010
Est. completion date November 2013

Study information

Verified date September 2012
Source Hologic, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Description:

Between 500 and 600 subjects will be enrolled in a prospective, multi-center registry study. Approximately 100 of these cases will be completed in an office setting, with the remaining 400-500 cases completed in a hospital outpatient or ambulatory surgery center. Subjects will undergo a hysteroscopic tissue removal procedure to remove intrauterine polyps and submucosal fibroids.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 600
Est. completion date November 2013
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
MyoSure Tissue Removal System
The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade. When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle.

Locations

Country Name City State
United States Hologic, Inc. Marlborough Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Hologic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Procedure Efficacy Mean percent of pathology removed, based on hysteroscopic assessment immediately following completion of the treatmet procedure 1 hour post treatment No
Secondary Percentage of subjects that achieve 100% removal of target pathology Percentage of subjects that achieve 100% removal of target pathology, as determined by hysteroscopic exam following the treatment procedures. 1 hour post treatment No
See also
  Status Clinical Trial Phase
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Completed NCT00958334 - Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003 Phase 2
Withdrawn NCT04567589 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada
Recruiting NCT05078307 - Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids N/A
Recruiting NCT02283502 - Clinical Test of the MRgHIFU System on Uterine Fibroids Phase 1
Completed NCT01631903 - Extension of Study ZPV-200 Phase 2
Completed NCT01739621 - Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200 Phase 2
Withdrawn NCT00768742 - Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study N/A
Completed NCT00152256 - A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids Phase 3
Not yet recruiting NCT03586947 - Association Between Vitamin D and the Risk of Uterine Fibroids N/A
Completed NCT02925494 - An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Phase 3
Not yet recruiting NCT06055114 - Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age
Terminated NCT05026502 - A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
Withdrawn NCT04567095 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada
Withdrawn NCT03699176 - Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Phase 3
Not yet recruiting NCT02884960 - Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization N/A
Completed NCT02472184 - Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy N/A
Terminated NCT01555073 - Preemptive Analgesia Following Uterine Artery Embolization Phase 4
Completed NCT01452659 - Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids Phase 2
Completed NCT01229826 - Magnetic Resonance Elastography (MRE) of Uterine Fibroids N/A