Leiomyoma, Menorrhagia, Uterine Fibroids
Conditions
Keywords
Uterine fibroids, Leiomyoma, Menorrhagia, Hysteroscopic cryoablation, Minimally invasive
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
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.
Interventions
PROCEDURECryoablation 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.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| Evaluation of Length of an Average Cryoablation Procedure | Post procedure | Evaluation of length of an average cryoablation procedure for the treatment of uterine fibroids |
| 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). |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cryoablation for the Treatment of Uterine Fibroids All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Cryoablation for the Treatment of Uterine Fibroids |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 46.3 years STANDARD_DEVIATION 1 |
| Region of Enrollment Netherlands | 3 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
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)
Time frame: up to 4 weeks post procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cryoablation for the Treatment of Uterine Fibroids | Number of Adverse Events | 1 Participants |
Secondary
Evaluation of Length of an Average Cryoablation Procedure
Evaluation of length of an average cryoablation procedure for the treatment of uterine fibroids
Time frame: Post procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cryoablation for the Treatment of Uterine Fibroids | Evaluation of Length of an Average Cryoablation Procedure | 65.3 Minutes |
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
Time frame: Prior to hospital discharge (less than 24 hours post-procedure)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cryoablation for the Treatment of Uterine Fibroids | Hysteroscopic Cryoablation Related Pain Will be Measured by Self Reported Pain Severity Visual Analogue Scale (VAS) Completed by the Patient | 1.86 Units on a scale from 1 to 10 |
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.
Time frame: Post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cryoablation for the Treatment of Uterine Fibroids | Number of Participants Discharged on Day of Cryoablation Procedure. | 3 Participants |
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).
Time frame: Post procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cryoablation for the Treatment of Uterine Fibroids | Physician's Satisfaction From the Ease and Convenience of the Cryoablation Procedure | 4.3 Score from 1 to 5 |
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.
Time frame: 4 weeks post procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cryoablation for the Treatment of Uterine Fibroids | Time (in Days) to Return to Normal Activity | 6 Days |