Sonata Uterine Preserving TrEatment CompaRed to Myomectomy for TIme tO Recovery Randomized Controlled Trial
Organizational Data
- DRKS-ID:
- DRKS00028847
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2022-04-22
- Last update in DRKS:
- 2023-01-03
- Registration type:
- Prospective
Acronym/abbreviation of the study
SUPERIOR RCT
URL of the study
No Entry
Brief summary in lay language
The purpose of this study is to determine how long it takes for patients to resume their normal activities after myoma treatment. The aim is to find out whether this time is shorter on average for patients treated with the Sonata procedure than for patients who have undergone myomectomy (surgical removal of myomas).
Brief summary in scientific language
Subjects randomized to the Sonata treatment will undergo TFA with the Sonata System, a CE marked and FDA-cleared medical device. The Sonata System consists of a reusable intrauterine ultrasound (IUUS) probe and a single-use disposable RFA handpiece with proprietary Graphical Guidance Software (GGS) for diagnosis and targeting. These components are integrated to provide the gynecologist with a real-time image-guided treatment system. Subjects will be treated under general anesthesia and after cervical dilatation in the standard fashion, will have the Sonata device inserted into the endometrial cavity under intrauterine sonographic guidance; thus, insertion of the device into the uterus is not done blindly. The IUUS probe is used to identify fibroids from within the uterine cavity and guide deployment of an introducer and needle electrodes into one or more targeted fibroids. The Sonata Graphical Guidance Software, also known as the SMART Guide®, is a real-time graphical overlay on the ultrasound display. By displaying the ellipsoidal region where the ablation will take place (ablation zone), along with a surrounding ellipsoid (thermal safety border) where tissue temperatures will be elevated, the SMART Guide provides a safe and accurately targeted fibroid ablation. After ablating one or more fibroids, the device is withdrawn, and the subject may be treated with standard nonsteroidal antiinflammatory medications as needed. There are no special medications or postoperative treatments that are needed. All medical care will be aligned with standard medical practices. Subjects randomized to myomectomy will undergo standard laparoscopic myomectomy, which is performed under general anesthesia and requires 3-4 incisions (typically 3 mm – 10 mm) within the umbilicus and lower abdomen to permit the insertion of the laparoscope and associated instrumentation via surgical trocars. A pneumoperitoneum (instillation of CO2 gas to distend the abdominal cavity) is created to enable safe insertion of the laparoscopic instrumentation. One or more hysterotomy incisions are made within the uterus from which fibroids are shelled out. Depending on the size of the fibroids, a laparoscopic power morcellator may be used with or without a tissue containment bag to morcellate the fibroids and remove them through a laparoscopic incision. The subject will then have her incisions closed after removal of the pneumoperitoneum. If the subject also has fibroids within the endometrial cavity (submucous fibroids), she will undergo hysteroscopic myomectomy during the same laparoscopic procedure, in which a small endoscope (hysteroscope) is placed into the endometrial cavity and fibroid tissue is resected and removed using a bipolar electrosurgical loop. Fluid (typically normal saline or lactated Ringers solution) is instilled using a fluid management system to distend the endometrial cavity and enable visualization and resection of fibroid tissue. Afterwards, the subject will require analgesia (typically nonsteroidals). All medical care will follow standard medical practices.
Health condition or problem studied
- ICD10:
- D25 - Leiomyoma of uterus
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- transcervical fibroid ablation using the Sonata-System
- Arm 2:
- standard laparoscopic myomectomy
Endpoints
- Primary outcome:
- The primary objective of the trial is to determine if Return to Normal Activity (RTNA) following TFA is shorter than that following a myomectomy procedure.
- Secondary outcome:
- procedure duration and details length of stay vitals and procedure recovery pain score during hospitalization and at discharge pain medications through 30 days as an indicator for procedure recovery number, maximal diameter, location, and type of fibroids treated time (days) to return to work, resume normal bowel movements, resumption of normal urinary function, resumption of a normal diet intraoperative, 30-day and 1-year serious device/procedure related adverse events (AEs) 6- and 12-month symptom severity score (SSS) and health-related quality of life outcomes (HRQL) using the Uterine Fibroid System and Quality of Life (UFS-QoL) questionnaire 6- and 12-month overall treatment effect (OTE) and subject satisfaction (OTE Subject Satisfaction Questionnaires) pregnancy occurrence and outcome relevant surgical reinterventions
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Department für Frauengesundheit Tübingen
Recruitment period and number of participants
- Planned study start date:
- 2022-06-03
- Actual study start date:
- 2022-06-03
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 120
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- Female
- Minimum Age:
- 18 Years
- Maximum Age:
- 50 Years
- Additional Inclusion Criteria:
- Subjects who meet all of the following conditions may be included: - Written informed consent - Women who are ≥ 18 and ≤ 50 years old - Have symptomatic uterine fibroids including heavy menstrual bleeding - Are seeking a uterus-preserving fibroid treatment - For whom TFA treatment with Sonata is deemed appropriate by their treating physicians - For whom fibroid treatment with laparoscopic myomectomy with OR without adjunct hysteroscopic myomectomy is appropriate - Have up to 10 non-pedunculated fibroids that are <8cm
Exclusion Criteria
- contraindicated for either TFA or laparoscopic myomectomy - in the opinion of the treating physician, the subject is not appropriate or suitable to participate in the trial (e.g., anovulation, adenomyosis, immunocompromised, woman who are pregnant or breast feeding)
Addresses
Primary Sponsor
- Address:
- Forschungsinstitut für FrauengesundheitProf. Dr. med. Sara BruckerCalwerstrasse 772076 TübingenGermany
- Telephone:
- 07071 29 82211
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Forschungsinstitut für FrauengesundheitProf. Dr. med. Sara BruckerCalwerstrasse 772076 TübingenGermany
- Telephone:
- 07071 29 82211
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Forschungsinstitut für FrauengesundheitProf. Dr. med. Sara BruckerCalwerstrasse 772076 TübingenGermany
- Telephone:
- 07071 29 82211
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Forschungsinstitut für FrauengesundheitProf. Dr. med. Sara BruckerCalwerstrasse 772076 TübingenGermany
- Telephone:
- 07071 29 82211
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Forschungsinstitut für FrauengesundheitCalwerstrasse 772076 TübingenGermany
- Telephone:
- 07071 29 82211
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum TübingenGartenstr. 4772074 TübingenGermany
- Telephone:
- +49-7071-2977661
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-12-06
- Ethics committee number:
- 896/2021BO1
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-03-07
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry