None listed
Conditions
Brief summary
This is a single-centre safety and feasibility study of a new device designed for the ablation of uterine tissue. Subjects with a specific condition will be enrolled where the new device will be used to deliver energy to abnormal uterine tissue; these subjects will be followed up to 1-year post-procedure. This is not a powered study, so there is no formal hypothesis. This research is an early feasibility study and will determine whether use of this new system is safe and feasible.
Interventions
The purpose of this research study is to assess the safety and feasibility of a new device designed for the ablation of uterine tissue. Subjects will have a procedure using a device that delivers energy to abnormal uterine tissue. The resected tissue will be analyzed to determine the characteristics of the energy applied to it. Qualified physicians will perform procedures in an operating room.
Subjects will undergo a procedure where a device which has an applicator will be used to deliver ener
The purpose of this research study is to assess the safety and feasibility of a new device designed for the ablation of uterine tissue. Subjects will have a procedure using a device that delivers energy to abnormal uterine tissue. The resected tissue will be analyzed to determine the characteristics of the energy applied to it. Qualified physicians will perform procedures in an operating room. Subjects will undergo a procedure where a device which has an applicator will be used to deliver energy to the uterus from inside the body, in subjects undergoing ablation for a specific condition. Images obtained during the procedure will be analysed to understand characteristics of the energy delivered to the tissue. Procedures will occur in an operating room and will be performed by qualified physicians. The study procedure will last for approximately 2 hours. Participants will be followed up for 12 months following the procedure.
Sponsors
Ascend Clinical Research Organisation, Pty Ltd.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female subject is greater than or equal to 22 years old at the time of consent. 2. Subject has MRI-determined diagnosis of adenomyosis 3. Subjects with a uterine size of up to 12cm and/or wall thickness of 6 cm. 4. Subject is within reproductive age or after reproductive age but not in menopause, as evaluated by the Investigator. 5. Subject is not seeking pregnancy after the Study Procedure or is unable to get pregnant due to anatomical or surgical reasons such as tubal ligation. 6. Subjects of child-bearing potential must not be pregnant as confirmed with a negative urine or serum beta human chorionic gonadotropin test prior to the index procedure, or lactating/breast-feeding.
Exclusion criteria
1. Subjects contraindicated for surgery or general anesthesia. 2. Subjects who require emergent hysterectomy. 3. Subjects who have suspicion or confirmation of gynecologic malignancy as evidenced by endometrial biopsy and/or radiologic imaging. 4. Subjects who have fibroids in the proximity of the target adenomyosis. 5. Subjects who are not candidates for the Study Procedure as determined by the Investigator during pre-operative health assessment. 6. Subjects with concomitant disease, that, in the opinion of the Investigator, could interfere with the study, including but not limited to pelvic inflammatory disease, deep infiltrating endometriosis, multiple fibroids obscuring the myometrium or junctional zone, pelvic congestion syndrome, AP malformation, intrauterine adhesions, or ovarian endometrioma > three (3) cm. 7. Subject previously underwent endometrial ablation, uterine artery embolization, high-intensity focused ultrasound, myomectomy, or any other uterine-preserving technique for reduction of menstrual bleeding. 8. Subjects with an implantable uterine or fallopian tube device for contraception that is unable to be removed prior to the procedure. 9. Subject with ferromagnetic implants. 10. Subject with estimated glomerular filtration rate (eGFR) less than 30 and/or had previous reaction to gadolinium. 11. Subjects who have taken gonadotropin-releasing hormone (GnRH) agonist or antagonist medication within three (3) months prior to baseline visit. 13. Subjects with clinically significant electrocardiogram (ECG) findings such as new clinically significant arrythmia or conduction disturbances. 14. Subjects with presence of any implanted electronic devices (e.g., cardiac pacemakers or defibrillators) that cannot be turned off during the procedure. 15. Subjects with implanted electronic devices or implants with metal parts in the immediate vicinity of the treatment area.
Outcome results
None listed