One or More Uterine FibroidsNCT03028610
Pregnancy Outcome Following Global Fibroid Ablation Using the Acessa™ System
A study testing radiofrequency generator in people with One or More Uterine Fibroids, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Prospective, interventional, single-center, longitudinal, single-arm pilot study to evaluate pregnancies following the Acessa™ treatment of uterine myomas in women who desire future childbearing Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- One or More Uterine Fibroids
- What is being tested?
- radiofrequency generator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2016to 13 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Are premenopausal and aged 18 to 40 years.
- Have already consented to have their fibroids treated with the Acessa™ procedure.
- Desire pregnancy within two years following Acessa™ treatment
- Have a normal endometrial cavity as delineated by sonohysterogram within 6 months prior to treatment.
- Have a uterine size relating to ≤14 weeks of pregnancy, as determined by palpatory pelvic exam.
- Have fibroids identified by transvaginal ultrasound with:
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- ≤6 (six) fibroids of ≤5 cm at the major diameter
- a total uterine volume of no greater than 300 cc
- Patients with type 2 fibroids are acceptable for inclusion.
- Are current in their screening for cervical cancer precursors (i.e. PAP 1 or 2).
- Are capable of providing informed consent.
- Are willing and able to comply with all study tests, procedures, and assessment tools during screening and up to 3 years post treatment.
- Are able to pass a pre-operative health exam (ASA I-III).
- Patients who are currently undergoing fertility treatments (e.g. Clomid, IVF, etc.) or who are planning such treatments may be enrolled in the study.
Who cannot join
- Have contraindications for laparoscopic surgery and/or general anesthesia.
- Have cervical myomas or Type 0 or Type 1 myomas. Type 0 and Type 1 myomas are excluded as these are generally accessible to hysteroscopic approaches. Cervical myomas are difficult to treat and present a greater risk of bladder or urethral injury.
- Have one or more Type 0 (completely intracavitary) or Type 1 resectable submucous fibroids.
- Have known or suspected abdominal adhesions which are expected to complicate laparoscopic surgery.
- Have known or suspected untreated intra-uterine adhesions or uterine septum.
- Have previously undergone endometrial ablation, uterine artery embolization, or uterine artery ligation/occlusion, high-intensity focused ultrasound, laparoscopic, hysteroscopic or abdominal myomectomy, or any other uterine-preserving technique for reduction of menstrual bleeding.
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- Subjects taking platelet-inhibiting drugs such as nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, and clopidogrel
- Are pregnant or lactating.
- Have known or suspected severe endometriosis.
- Have known or suspected adenomyosis.
- Have active or history of pelvic inflammatory disease.
- Have a history of or evidence of gynecologic malignancy or pre-malignancy within the past five years.
- Have had pelvic radiation.
- Have a persistent and undiagnosed complex adnexal mass.Are unable to give informed consent.
- In the medical judgment of the investigator should not participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Prospective, interventional, single-center, longitudinal, single-arm pilot study to evaluate pregnancies following the Acessa™ treatment of uterine myomas in women who desire future childbearing
- Conditions
- One or More Uterine Fibroids
- Being tested
- radiofrequency generator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency generatorDevice
| Study group | Role | What they receive |
|---|---|---|
| Acessa™ System | Experimental | radiofrequency generator Receives: Device: radiofrequency generator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous abortion
Measured: 6 months
Ectopic pregnancy
Measured: three years
Vaginal delivery and either
- Uncomplicated delivery or ii. Delivery with complications such as:
- Premature rupture of the membranes (PROM) or
- Preterm premature rupture of the membranes (PPROM)
Measured: three years
Caesarean section delivery and either
- Uncomplicated delivery or ii. Delivery with complications such as:
- Preterm delivery
- Preterm labor
- Uterine rupture
- Stillbirths
- Postpartum
Measured: three years
Secondary outcomes (4)
Procedure-related complications within 1 month post-procedure
Measured: 1 month
Post-treatment readmission and reintervention rate within 1 month post-procedure assessed by questionnairie
Measured: 1 month
Post-treatment changes in menstrual status up to 36 months post-procedure assessed by a menstrual impact score
Measured: three years
Post-treatment changes in myoma size as determined by ultrasound
Measured: 3, 6, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start1 Jan 2016
- Primary completion13 Jul 2023
- Study completion13 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for One or More Uterine FibroidsStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Y Brucker, MD, Principal investigator, University Women's Hospital, Calwerstrasse 7, 72076 Tübingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028610
- Sponsor's protocol ID
- GFA-001
- Status last verified
- Dec 2024
- First submitted
- 2 Aug 2016
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Outcome Following Global Fibroid Ablation Using the Acessa™ System
- ClinicalTrials.gov ID
- NCT03028610
- Acronym / sponsor ID
- GFA-001
- Conditions
- One or More Uterine Fibroids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 13 Jul 2023 (actual)
- Study completion
- 13 Aug 2023 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, interventional, single-center, longitudinal, single-arm pilot study to evaluate pregnancies following the Acessa™ treatment of uterine myomas in women who desire future childbearing
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acessa™ System | Experimental | Device: radiofrequency generatorradiofrequency generator |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Are premenopausal and aged 18 to 40 years.
- Have already consented to have their fibroids treated with the Acessa™ procedure.
- Desire pregnancy within two years following Acessa™ treatment
- Have a normal endometrial cavity as delineated by sonohysterogram within 6 months prior to treatment.
- Have a uterine size relating to ≤14 weeks of pregnancy, as determined by palpatory pelvic exam.
Key exclusion criteria (15 listed)
- Have contraindications for laparoscopic surgery and/or general anesthesia.
- Have cervical myomas or Type 0 or Type 1 myomas. Type 0 and Type 1 myomas are excluded as these are generally accessible to hysteroscopic approaches. Cervical myomas are difficult to treat and present a greater risk of bladder or urethral injury.
- Have one or more Type 0 (completely intracavitary) or Type 1 resectable submucous fibroids.
- Have known or suspected abdominal adhesions which are expected to complicate laparoscopic surgery.
- Have known or suspected untreated intra-uterine adhesions or uterine septum.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiofrequency generator | Device | Acessa™ System |
Primary outcome
Spontaneous abortion
Time frame: 6 months
Ectopic pregnancy
Time frame: three years
Vaginal delivery and either
Time frame: three years
i. Uncomplicated delivery or ii. Delivery with complications such as: * Premature rupture of the membranes (PROM) or * Preterm premature rupture of the membranes (PPROM)
Caesarean section delivery and either
Time frame: three years
i. Uncomplicated delivery or ii. Delivery with complications such as: * Preterm delivery * Preterm labor * Uterine rupture * Stillbirths * Postpartum
4 secondary outcomes
Procedure-related complications within 1 month post-procedure
Time frame: 1 month
Post-treatment readmission and reintervention rate within 1 month post-procedure assessed by questionnairie
Time frame: 1 month
Post-treatment changes in menstrual status up to 36 months post-procedure assessed by a menstrual impact score
Time frame: three years
Post-treatment changes in myoma size as determined by ultrasound
Time frame: 3, 6, 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Y Brucker, MD principal investigator
University Women's Hospital, Calwerstrasse 7, 72076 Tübingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiofrequency generator in people with One or More Uterine Fibroids, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous abortion (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.