Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Hysteroscopic Cryomyolysis for the Treatment of Submucosal Leiomyomata

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galil Medical
ClinicalTrials.gov Identifier:
NCT00731341
First received: August 7, 2008
Last updated: October 25, 2011
Last verified: October 2011
Results First Received: August 12, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Uterine Fibroids
Leiomyoma
Menorrhagia
Intervention: Procedure: Cryoablation for the treatment of uterine fibroids

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cryoablation for the Treatment of Uterine Fibroids All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids

Participant Flow:   Overall Study
    Cryoablation for the Treatment of Uterine Fibroids  
STARTED     3  
COMPLETED     3  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cryoablation for the Treatment of Uterine Fibroids All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids

Baseline Measures
    Cryoablation for the Treatment of Uterine Fibroids  
Number of Participants  
[units: participants]
  3  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  46.3  ± 1  
Gender  
[units: participants]
 
Female     3  
Male     0  
Region of Enrollment  
[units: participants]
 
Netherlands     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Adverse Events   [ Time Frame: up to 4 weeks post procedure. ]

2.  Secondary:   Hysteroscopic Cryoablation Related Pain Will be Measured by Self Reported Pain Severity Visual Analogue Scale (VAS) Completed by the Patient   [ Time Frame: Prior to hospital discharge (less than 24 hours post-procedure) ]

3.  Secondary:   Time (in Days) to Return to Normal Activity   [ Time Frame: 4 weeks post procedure ]

4.  Secondary:   Number of Participants Discharged on Day of Cryoablation Procedure.   [ Time Frame: Post procedure ]

5.  Secondary:   Evaluation of Length of an Average Cryoablation Procedure   [ Time Frame: Post procedure ]

6.  Secondary:   Physician's Satisfaction From the Ease and Convenience of the Cryoablation Procedure   [ Time Frame: Post procedure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to the nature of this feasibility study, a very small number of participants was evaluated.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Joy Benson, CRA
Organization: Galil Medical
phone: 651-287-5112
e-mail: joy.benson@galilmedical.com


No publications provided


Responsible Party: Galil Medical
ClinicalTrials.gov Identifier: NCT00731341     History of Changes
Other Study ID Numbers: UFHYS_WH_ 121207 VER 0.1
Study First Received: August 7, 2008
Results First Received: August 12, 2010
Last Updated: October 25, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)