Hysteroscopic Cryomyolysis for the Treatment of Submucosal Leiomyomata

NCT00731341 | Completed Results

• 1 other identifier: UFHYS_WH_ 121207 VER 0.1
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the current study is to evaluate the technical success, safety and procedure feasibility of hysteroscopic cryoablation treatment of symptomatic uterine fibroids in women who do not desire further pregnancies using Galil Medical's 17-gauge 400mm Argon-based cryoablation needles

Conditions

Uterine Fibroids; Leiomyoma; Menorrhagia

Keywords

Uterine fibroids; Leiomyoma; Menorrhagia; Hysteroscopic cryoablation; Minimally invasive

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  Safety of the procedure will be assessed by incidence and severity of intra and post procedure related adverse events (AEs)

  up to 4 weeks post procedure.

Secondary Outcomes (5)

• Hysteroscopic Cryoablation Related Pain Will be Measured by Self Reported Pain Severity Visual Analogue Scale (VAS) Completed by the Patient

  Prior to hospital discharge (less than 24 hours post-procedure)

• Time (in Days) to Return to Normal Activity

  4 weeks post procedure

• Number of Participants Discharged on Day of Cryoablation Procedure.

  Post procedure

• Evaluation of Length of an Average Cryoablation Procedure

  Post procedure

• Physician's Satisfaction From the Ease and Convenience of the Cryoablation Procedure

  Post procedure

Study Arms (1)

Hysteroscopic cryoablation

EXPERIMENTAL

Women undergoing hysteroscopic ultrasound guided cryoablation for the treatment of uterine fibroids.

Procedure: Cryoablation for the treatment of uterine fibroids

Interventions

Cryoablation for the treatment of uterine fibroids PROCEDURE

Needle will be inserted into the fibroid via the cervix through a hysteroscope channel. Gas is circulated through the sealed needle to form an iceball at the tip. After insertion, the needle will be cooled to a temperature of below -100°C to freeze the tissue of the fibroid.

Also known as: Presice Cryoablation System, 17-gauge IceBulb™ needle Lot G3021

Hysteroscopic cryoablation

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primary complaint is excessive bleeding
• Subject is able to understand and give informed consent for participation in the study
• Pre-menopausal woman between the ages of 30 and 50 (inclusive)
• Has completed childbearing and not contemplating future fertility
• Has symptomatic uterine fibroids
• Fibroids type, size, location and number
• submucosal fibroid
• Type I and Type II fibroids
• to 4cm
• Using contraception to prevent pregnancy

You may not qualify if:

• Any evidence of known or suspected infection or pre-malignancy/malignancy
• Desire for future child bearing
• Fibroids
• Size \> 4cm
• or more submucosal fibroids
• Fibroid distance from the serosa is less than 1 cm

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

St.Lucas Andreas Ziekenhuis

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Leiomyoma; Menorrhagia

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Limitations and Caveats

Due to the nature of this feasibility study, a very small number of participants was evaluated.

Results Point of Contact

• Title: Joy Benson, CRA
• Organization: Galil Medical

joy.benson@galilmedical.com

651-287-5112

Study Officials

• Andreas L Thurkow

  St.Lucas Andreas Ziekenhuis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 11, 2008
• Study Start: July 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: July 19, 2021
• Results First Posted: July 1, 2011

Record last verified: 2021-07

Locations

NL (1)