The primary objective of this study is to evaluate feasibility of performing MR-HIFU treatment of uterine fibroids in a Philips Sonalleve MR-HIFU system equipped with a Direct Skin Cooling device. Secondary objective is evaluation of safety.
ID
Source
Brief title
Condition
- Reproductive neoplasms female benign
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility of MR-HIFU treatment with Sonalleve with Direct Skin Cooling will
be measured by recording whether treatments are completed successfully using
the investigational device. Treatment completion will be judged by the treating
physician and recorded in the Case Report Form (CRF).
The rate of successful treatment completion will be determined. An individual
treatment is deemed successful if the treating physician is able to complete
the treatment as planned using the MR-HIFU device with Direct Skin Cooling. If
a treatment needs to be aborted before the desired ablation volume is achieved,
as judged by the treating physician, it will be counted as a failure. If the
backup CE-labeled Sonalleve device without Direct Skin Cooling needs to be used
to complete the treatment, it will be counted as a failure.
Secondary outcome
The following measurements will be performed to gain additional insight into
safety and feasibility of the treatment with the Philips Sonalleve MR-HIFU
device with Direct Skin Cooling:
1. Safety Endpoint:
Incidence of adverse events and Serious Adverse Events will be recorded in the
CRF, and their relatedness to the investigational device and the study in
general will be assessed.
2. Physician Acceptance:
Acceptance of the device by the treating physician will be evaluated by
determination of the Net Promoter Score. After each treatment, the treating
physician will be asked the question *How likely is it that you would recommend
this device to your colleagues?* Answers will be recorded as a score from 0 to
10, with 0 being the least likely and 10 being the most likely. The result will
be recorded in the CRF.
Background summary
During MR-HIFU treatments, undesired warming outside of the targeted area may
occur due to the deposition of thermal energy. In standard MR-HIFU therapy, the
effects of this undesired warming are mitigated e.g. by enforcement of cooling
periods between ultrasound applications. Introduction of a cooled interface
which allows direct cooling of the patients* skin can further mitigate
undesired warming, potentially increasing treatment efficiency and providing an
additional safety buffer. This feasibility trial is designed to demonstrate the
concept for a Direct Skin Cooling device added to the Philips Sonalleve MR-HIFU
device for uterine fibroid treatments.
Study objective
The primary objective of this study is to evaluate feasibility of performing
MR-HIFU treatment of uterine fibroids in a Philips Sonalleve MR-HIFU system
equipped with a Direct Skin Cooling device. Secondary objective is evaluation
of safety.
Study design
Prospective, non-randomized feasibility study (Proof of Concept).
Study burden and risks
Risk assessment has concluded that the overall risk level does not differ from
the CE-marked Sonalleve system. One additional risk mechanism potentially
leading to an adverse event was identified as specifically related to the
cooling device. The adverse event associated with this mechanism is a
non-freezing cold injury to the patients* skin, due to prolonged exposure to
the cooled surface. Due to the temperature and exposure time limitations in
this protocol, the probability of occurrence for this specific event is
considered remote.
In case the treatment cannot be successfully completed using the device with
Direct Skin Cooling, treatment with a normal, CE-marked Sonalleve device will
be available to the patients.
Äyritie 4
Vantaa FI-01510
FI
Äyritie 4
Vantaa FI-01510
FI
Listed location countries
Age
Inclusion criteria
Patient selected for MR-HIFU treatment of Uterine Fibroids or Adenomyosis.
Age >= 18 years.
Patient capable of giving informed consent in writing and able to attend study visits.
Exclusion criteria
Discretion of the principal investigator, e.g. in presence of clinically relevant medical history or abnormal physical findings that could interfere with the safety of the participant.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL45458.041.13 |