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Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids (OPEN)

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ClinicalTrials.gov Identifier: NCT02844920
Recruitment Status : Completed
First Posted : July 26, 2016
Results First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Gynesonics

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Uterine Fibroids
Adhesions
Intervention Device: Intrauterine ultrasound guided radio-frequency ablation
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fibroid Treatment
Hide Arm/Group Description

Intrauterine ultrasound guided radio-frequency ablation

Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids

Period Title: Overall Study
Started 37
Completed Without Evaluable Videos 1 [1]
Completed With Evaluable Videos 34 [2]
Completed, Eval. Data, Opposing Fibroids 6 [3]
Completed 35 [4]
Not Completed 2
Reason Not Completed
Lost to Follow-up             2
[1]
Participants with completed the follow-up but without evaluable hysteroscopy videos
[2]
Participants with completed the follow-up and evaluable hysteroscopy videos
[3]
Participants with completed the follow-up, evaluable hysteroscopy videos, and opposing fibroids
[4]
Participants with completed the follow-up
Arm/Group Title Fibroid Treatment
Hide Arm/Group Description Intrauterine ultrasound guided radio-frequency ablation Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids
Overall Number of Baseline Participants 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants
42.4  (7.17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Female
37
 100.0%
Male
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 37 participants
25.4  (5.23)
1.Primary Outcome
Title Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids
Hide Description Hysteroscopic evaluation by independent readers to determine the presence or absence of adhesions following transcervical RF ablation of fibroids with the Sonata system in participants who completed the follow-up assessment AND evaluable hysteroscopy videos.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with completed follow-up assessment and had evaluable hysteroscopy videos.
Arm/Group Title Fibroid Treatment
Hide Arm/Group Description:

Intrauterine ultrasound guided radio-frequency ablation

Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids

Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
34
 100.0%
2.Secondary Outcome
Title Umber of Participants With Absence of Newly Formed Adhesions Following RF Ablation of Fibroids in Participants With Apposing Fibroids Treated
Hide Description As the risk of adhesion formation is higher when apposing fibroids are treated, this outcome measure assesses adhesiogenesis in the subgroup of the population who completed the follow-up assessment, had evaluable hysteroscopy videos, and had apposing fibroids treated.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the follow-up assessment, had evaluable hysteroscopy videos, and had apposing fibroids treated.
Arm/Group Title Fibroid Treatment
Hide Arm/Group Description:

Intrauterine ultrasound guided radio-frequency ablation

Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids

Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
6
 100.0%
Time Frame 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fibroid Treatment
Hide Arm/Group Description

Intrauterine ultrasound guided radio-frequency ablation

Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids

All-Cause Mortality
Fibroid Treatment
Affected / at Risk (%)
Total   0/37 (0.00%)    
Hide Serious Adverse Events
Fibroid Treatment
Affected / at Risk (%) # Events
Total   1/37 (2.70%)    
Hepatobiliary disorders   
Gall Stones   1/37 (2.70%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fibroid Treatment
Affected / at Risk (%) # Events
Total   0/37 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Taraneh G. Farazi, Ph.D. (Vice President, Clinical Affairs)
Organization: Gynesonics
Phone: 650-216-3878
EMail: tfarazi@gynesonics.com
Layout table for additonal information
Responsible Party: Gynesonics
ClinicalTrials.gov Identifier: NCT02844920    
Other Study ID Numbers: CL04897
First Submitted: July 22, 2016
First Posted: July 26, 2016
Results First Submitted: August 12, 2019
Results First Posted: September 20, 2019
Last Update Posted: September 20, 2019