None listed
Conditions
Brief summary
This is a single-center safety and feasibility study of a new device designed for the ablation of uterine tissue. The study will enrol subjects planning to undergo a surgical procedure where the new device will be used and tissue analysed after extraction. 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 undergo a procedure where a device which has an applicator will be used to deliver energy to the uterus from inside the body, immediately prior to a planned, elective benign hysterectomy. Tissue extracted during the planned resection will be analysed to understand characteristics of the energy delivered to the tissue. Procedures will occur in an
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 undergo a procedure where a device which has an applicator will be used to deliver energy to the uterus from inside the body, immediately prior to a planned, elective benign hysterectomy. Tissue extracted during the planned resection 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 30 minutes. Participants will be followed up approximately 30 days following the procedure. Details of the intervention ingredients will be provided on the ANZCTR registry at the end of IP assessment.
Sponsors
Ascend Clinical Research Organization, 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 consent. 2. Subject is planning to undergo elective hysterectomy for a benign gynaecologic condition.
Exclusion criteria
1. Subjects who require emergent hysterectomy. 2. Subjects who are not surgical candidates as determined by the Investigator during pre-operative health assessment. 3. Subjects who have suspicion or confirmation of gynaecologic malignancy as evidenced by endometrial biopsy and/or radiologic imaging. 4. Subjects with clinically significant electrocardiogram (ECG) findings such as new clinically significant arrythmia or conduction disturbances. 5. Subjects with presence of any implanted electronic devices that cannot be turned off during the procedure.
Outcome results
None listed