Uterine FibroidsNCT00731341
Hysteroscopic Cryomyolysis for the Treatment of Submucosal Leiomyomata
A study testing Cryoablation for the treatment of uterine fibroids in people with Uterine Fibroids and Leiomyoma, run by Boston Scientific Corporation at 1 site in Netherlands.
Trial 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 Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Uterine Fibroids, Leiomyoma, Menorrhagia
- What is being tested?
- Cryoablation for the treatment of uterine fibroids
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2008to Feb 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 1 submucosal fibroid
- Type I and Type II fibroids
- 2 to 4cm
- Using contraception to prevent pregnancy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of Hysteroscopic Cryoablation Treatment of Symptomatic Uterine Fibroids in Women Who do Not Desire Further Pregnancies
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
Read the 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.
- Conditions
- Uterine Fibroids, Leiomyoma, Menorrhagia
- Being tested
- Cryoablation for the treatment of uterine fibroids
- Keywords
- Uterine fibroids, Leiomyoma, Menorrhagia, Hysteroscopic cryoablation, Minimally invasive
- Medical subject headings
- Leiomyoma, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoablation for the treatment of uterine fibroidsProcedure or surgery
Also called Presice Cryoablation System, 17-gauge IceBulb™ needle Lot G3021
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.
| Study group | Role | What they receive |
|---|---|---|
| Hysteroscopic cryoablation | Experimental | Women undergoing hysteroscopic ultrasound guided cryoablation for the treatment of uterine fibroids. Receives: Procedure: Cryoablation for the treatment of uterine fibroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Safety of the procedure will be assessed by incidence and severity of intra and post procedure related adverse events (AEs)
Measured: 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
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
Measured: Prior to hospital discharge (less than 24 hours post-procedure)
Time (in Days) to Return to Normal Activity
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.
Measured: 4 weeks post procedure
Number of Participants Discharged on Day of Cryoablation 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.
Measured: Post procedure
Evaluation of Length of an Average Cryoablation Procedure
Evaluation of length of an average cryoablation procedure for the treatment of uterine fibroids
Measured: Post procedure
Physician's Satisfaction From the Ease and Convenience of the Cryoablation Procedure
Physician's satisfaction from the ease and convenience of the cryoablation procedure using a scale of 1 (very satisfied) to 5 (very dissatisfied).
Measured: Post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreas L Thurkow, Principal investigator, St.Lucas Andreas Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731341
- Sponsor's protocol ID
- UFHYS_WH_ 121207 VER 0.1
- Status last verified
- Jul 2021
- First submitted
- 7 Aug 2008
- Last updated
- 19 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Hysteroscopic Cryoablation Treatment of Symptomatic Uterine Fibroids in Women Who do Not Desire Further Pregnancies
- ClinicalTrials.gov ID
- NCT00731341
- Acronym / sponsor ID
- UFHYS_WH_ 121207 VER 0.1
- Conditions
- Uterine Fibroids, Leiomyoma, Menorrhagia
- Keywords
- Uterine fibroids, Leiomyoma, Menorrhagia, Hysteroscopic cryoablation, Minimally invasive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 11 Aug 2008 (estimated)
- Results
- Posted 1 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hysteroscopic cryoablation | Experimental | Procedure: Cryoablation for the treatment of uterine fibroidsWomen undergoing hysteroscopic ultrasound guided cryoablation for the treatment of uterine fibroids. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- Any evidence of known or suspected infection or pre-malignancy/malignancy
- Desire for future child bearing
- Fibroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryoablation for the treatment of uterine fibroidsAlso: Presice Cryoablation System, 17-gauge IceBulb™ needle Lot G3021Needle 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. | Procedure or surgery | Hysteroscopic cryoablation |
Primary outcome
Number of Adverse Events
Time frame: 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)
5 secondary outcomes
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)
Time (in Days) to Return to Normal Activity
Time frame: 4 weeks post procedure
Number of Participants Discharged on Day of Cryoablation Procedure.
Time frame: Post procedure
Evaluation of Length of an Average Cryoablation Procedure
Time frame: Post procedure
Physician's Satisfaction From the Ease and Convenience of the Cryoablation Procedure
Time frame: Post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas L Thurkow principal investigator
St.Lucas Andreas Ziekenhuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation for the treatment of uterine fibroids in people with Uterine Fibroids and Leiomyoma, run by Boston Scientific Corporation at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: up to 4 weeks post procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.