Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hysteroscopic cryoablation | Experimental | Women undergoing hysteroscopic ultrasound guided cryoablation for the treatment of uterine fibroids. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Prior to hospital discharge (less than 24 hours post-procedure) |
Not provided
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
Using contraception to prevent pregnancy
Exclusion Criteria:
Any evidence of known or suspected infection or pre-malignancy/malignancy
Desire for future child bearing
Fibroids
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andreas L Thurkow | St.Lucas Andreas Ziekenhuis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St.Lucas Andreas Ziekenhuis | Amsterdam | Netherlands |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cryoablation for the Treatment of Uterine Fibroids | All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cryoablation for the Treatment of Uterine Fibroids | All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Adverse Events | Safety of the procedure will be assessed by incidence and severity of intra and post procedure related adverse events (AEs) | Posted | Number | Participants | up to 4 weeks post procedure. |
|
|
up to 4 weeks post-procedure
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cryoablation for the Treatment of Uterine Fibroids | All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burning sensation in lower abdomen | Reproductive system and breast disorders | Systematic Assessment | This AE occurred in one subject and lasted 6 days before self-resolving. The severity was reported as MILD. |
Due to the nature of this feasibility study, a very small number of participants was evaluated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joy Benson, CRA | Galil Medical | 651-287-5112 | joy.benson@galilmedical.com |
Not provided
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D008595 | Menorrhagia |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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. | 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. | Post procedure |
| Evaluation of Length of an Average Cryoablation Procedure | Evaluation of length of an average cryoablation procedure for the treatment of uterine fibroids | 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). | Post procedure |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | 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 | Posted | Mean | Full Range | Units on a scale from 1 to 10 | Prior to hospital discharge (less than 24 hours post-procedure) |
|
|
|
| Secondary | 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. | Posted | Mean | Full Range | Days | 4 weeks post procedure |
|
|
|
| Secondary | 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. | Posted | Number | Participants | Post procedure |
|
|
|
| Secondary | Evaluation of Length of an Average Cryoablation Procedure | Evaluation of length of an average cryoablation procedure for the treatment of uterine fibroids | Posted | Mean | Full Range | Minutes | Post procedure |
|
|
|
| Secondary | 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). | Posted | Mean | Full Range | Score from 1 to 5 | Post procedure |
|
|
|
| 0 |
| 3 |
| 1 |
| 3 |
|
Not provided
Not provided
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |