Hysteroscopic Cryomyolysis for the Treatment of Submucosal Leiomyomata

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00731341
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arm: 1
• Duration (Months): 7.1
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Uterine Fibroids; Leiomyoma; Menorrhagia	Procedure: Cryoablation for the treatment of uterine fibroids	N/A

Detailed Description

Currently there are no optimal methods for treating symptomatic uterine fibroids. Existing therapeutic options are conservative (medications), invasive (e.g., hysterectomy, surgical myomectomy), or minimally invasive (uterine artery embolization, or myolysis).

Fibroid ablation using cryogenic energy, known as Cryoablation, offers a potential alternative method of fibroid treatment. Cryotherapy is a well-established technique for the treatment of various benign and malignant conditions. Cryoablation has been described for the treatment of prostate cancer, renal cell carcinoma, liver tumors and benign and malignant breast tumors.

Galil Medical's proposed feasibility study is looking to examine the technical success, safety and feasibility of a hysteroscopic approach for the treatment of symptomatic fibroids. This technique involves the insertion and placement of Galil Medical's 17-gauge cryoablation needle(s)guided by a hysteroscopic device. Ultrasound provides real-time monitoring of the needle insertion, placement and iceball propagation during the cryoablation procedure.

This treatment offers the patient to preserve her uterus by a minimally invasive procedure. The type of the fibroids intended for treatment (Type II submucous myomas)are often very difficult to completely and safely remove hysteroscopically and are often treated through an open or laparoscopic procedure. A hysteroscopic procedure does not involve intraperitoneal intervention and is therefore expected to be associated with less intra-operative and post-operative complications.

The recovery from hysteroscopic cryoablation is expected to be fast with only minimal self resolving discomfort. The patient should be able to return to her normal activity within 24-48 hours.

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility Study of Hysteroscopic Cryoablation Treatment of Symptomatic Uterine Fibroids in Women Who do Not Desire Further Pregnancies
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

Arm

Intervention/Treatment

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

Procedure: Cryoablation for the treatment of uterine fibroids; 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.; Other Names: Presice Cryoablation System 17-gauge IceBulb™ needle Lot G3021

Outcome Measures

Primary Outcome Measures

1. Number of Adverse Events [up to 4 weeks post procedure.]

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

Secondary Outcome Measures

1. 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)]

   Hysteroscopic cryoablation related pain will be measured by self reported pain severity Visual Analogue Scale (VAS) from a scale of 1 (no pain) to 10 (very severe pain) completed by the patient

2. Time (in Days) to Return to Normal Activity [4 weeks post procedure]

   The number of days needed to return to normal activity was assessed by the participant and reported to the investigator. The response was documented at follow-up.

3. Number of Participants Discharged on Day of Cryoablation Procedure. [Post procedure]

   Per the protocol, this outcome intended to report the average duration of post operative hospital stay. However, this measurement was made very generally and was not collected in number of hours, only the dates were collected. The only actual data that can be stated is that all subjects were discharged from the hospital on the same day as the procedure. In order to report the average length of hospital stay, the wording on the outcome measure title has been changed.

4. Evaluation of Length of an Average Cryoablation Procedure [Post procedure]

   Evaluation of length of an average cryoablation procedure for the treatment of uterine fibroids

5. Physician's Satisfaction From the Ease and Convenience of the Cryoablation Procedure [Post procedure]

   Physician's satisfaction from the ease and convenience of the cryoablation procedure using a scale of 1 (very satisfied) to 5 (very dissatisfied).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

• 1 submucosal fibroid

• Type I and Type II fibroids

• 2 to 4cm

• Using contraception to prevent pregnancy

Exclusion Criteria:

• Any evidence of known or suspected infection or pre-malignancy/malignancy

• Desire for future child bearing

• Fibroids

• Size > 4cm

• 2 or more submucosal fibroids

• Fibroid distance from the serosa is less than 1 cm

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St.Lucas Andreas Ziekenhuis	Amsterdam		Netherlands

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Andreas L Thurkow, St.Lucas Andreas Ziekenhuis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT00731341
• Other Study ID Numbers: UFHYS_WH_ 121207 VER 0.1
• First Posted: Aug 11, 2008
• Last Update Posted: Jul 19, 2021
• Last Verified: Jul 1, 2021

• Keywords provided by Boston Scientific Corporation: Uterine fibroids; Leiomyoma; Menorrhagia; Hysteroscopic cryoablation; Minimally invasive
• Additional relevant MeSH terms: Leiomyoma; Myofibroma; Menorrhagia

Study Results

Participant Flow

Arm/Group Title	Cryoablation for the Treatment of Uterine Fibroids
Arm/Group Description	All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
Period Title: Overall Study
STARTED	3
COMPLETED	3
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Cryoablation for the Treatment of Uterine Fibroids
Arm/Group Description	All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
Overall Participants	3
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	3 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.3 (1)
Sex: Female, Male (Count of Participants)
Female	3 100%
Male	0 0%
Region of Enrollment (participants) [Number]
Netherlands	3 100%

Outcome Measures

1. Primary Outcome

Title	Number of Adverse Events
Description	Safety of the procedure will be assessed by incidence and severity of intra and post procedure related adverse events (AEs)
Time Frame	up to 4 weeks post procedure.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cryoablation for the Treatment of Uterine Fibroids
Arm/Group Description	All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
Measure Participants	3
Number [Participants]	1 33.3%

2. Secondary Outcome

Title	Hysteroscopic Cryoablation Related Pain Will be Measured by Self Reported Pain Severity Visual Analogue Scale (VAS) Completed by the Patient
Description	Hysteroscopic cryoablation related pain will be measured by self reported pain severity Visual Analogue Scale (VAS) from a scale of 1 (no pain) to 10 (very severe pain) completed by the patient
Time Frame	Prior to hospital discharge (less than 24 hours post-procedure)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cryoablation for the Treatment of Uterine Fibroids
Arm/Group Description	All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
Measure Participants	3
Mean (Full Range) [Units on a scale from 1 to 10]	1.86

3. Secondary Outcome

Title	Time (in Days) to Return to Normal Activity
Description	The number of days needed to return to normal activity was assessed by the participant and reported to the investigator. The response was documented at follow-up.
Time Frame	4 weeks post procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cryoablation for the Treatment of Uterine Fibroids
Arm/Group Description	All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
Measure Participants	3
Mean (Full Range) [Days]	6

4. Secondary Outcome

Title	Number of Participants Discharged on Day of Cryoablation Procedure.
Description	Per the protocol, this outcome intended to report the average duration of post operative hospital stay. However, this measurement was made very generally and was not collected in number of hours, only the dates were collected. The only actual data that can be stated is that all subjects were discharged from the hospital on the same day as the procedure. In order to report the average length of hospital stay, the wording on the outcome measure title has been changed.
Time Frame	Post procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cryoablation for the Treatment of Uterine Fibroids
Arm/Group Description	All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
Measure Participants	3
Number [Participants]	3 100%

5. Secondary Outcome

Title	Evaluation of Length of an Average Cryoablation Procedure
Description	Evaluation of length of an average cryoablation procedure for the treatment of uterine fibroids
Time Frame	Post procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cryoablation for the Treatment of Uterine Fibroids
Arm/Group Description	All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
Measure Participants	3
Mean (Full Range) [Minutes]	65.3

6. Secondary Outcome

Title	Physician's Satisfaction From the Ease and Convenience of the Cryoablation Procedure
Description	Physician's satisfaction from the ease and convenience of the cryoablation procedure using a scale of 1 (very satisfied) to 5 (very dissatisfied).
Time Frame	Post procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cryoablation for the Treatment of Uterine Fibroids
Arm/Group Description	All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
Measure Participants	3
Mean (Full Range) [Score from 1 to 5]	4.3

Adverse Events

Time Frame	up to 4 weeks post-procedure
Arm/Group Title	Cryoablation for the Treatment of Uterine Fibroids
Arm/Group Description	All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
All Cause Mortality
	Cryoablation for the Treatment of Uterine Fibroids
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Cryoablation for the Treatment of Uterine Fibroids
	Affected / at Risk (%)	# Events
Total	0/3 (0%)
Other (Not Including Serious) Adverse Events
	Cryoablation for the Treatment of Uterine Fibroids
	Affected / at Risk (%)	# Events
Total	1/3 (33.3%)
Reproductive system and breast disorders
Burning sensation in lower abdomen	1/3 (33.3%)	1

Limitations/Caveats

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

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.