Pregnancy Outcome Following Global Fibroid Ablation Using the Acessa™ System
NCT ID: NCT03028610
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2016-01-01
2023-08-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Acessa™ System
radiofrequency generator
radiofrequency generator
Interventions
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radiofrequency generator
Eligibility Criteria
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Inclusion Criteria
2. Have already consented to have their fibroids treated with the Acessa™ procedure.
3. Desire pregnancy within two years following Acessa™ treatment
4. Have a normal endometrial cavity as delineated by sonohysterogram within 6 months prior to treatment.
5. Have a uterine size relating to ≤14 weeks of pregnancy, as determined by palpatory pelvic exam.
6. Have fibroids identified by transvaginal ultrasound with:
1. ≤6 (six) fibroids of ≤5 cm at the major diameter
2. a total uterine volume of no greater than 300 cc
7. Patients with type 2 fibroids are acceptable for inclusion.
8. Are current in their screening for cervical cancer precursors (i.e. PAP 1 or 2).
9. Are capable of providing informed consent.
10. Are willing and able to comply with all study tests, procedures, and assessment tools during screening and up to 3 years post treatment.
11. Are able to pass a pre-operative health exam (ASA I-III).
12. Patients who are currently undergoing fertility treatments (e.g. Clomid, IVF, etc.) or who are planning such treatments may be enrolled in the study.
Exclusion Criteria
2. 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.
3. Have one or more Type 0 (completely intracavitary) or Type 1 resectable submucous fibroids.
4. Have known or suspected abdominal adhesions which are expected to complicate laparoscopic surgery.
5. Have known or suspected untreated intra-uterine adhesions or uterine septum.
6. 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.
7. Subjects taking platelet-inhibiting drugs such as nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, and clopidogrel
8. Are pregnant or lactating.
9. Have known or suspected severe endometriosis.
10. Have known or suspected adenomyosis.
11. Have active or history of pelvic inflammatory disease.
12. Have a history of or evidence of gynecologic malignancy or pre-malignancy within the past five years.
13. Have had pelvic radiation.
14. Have a persistent and undiagnosed complex adnexal mass.Are unable to give informed consent.
15. In the medical judgment of the investigator should not participate in the study.
18 Years
40 Years
FEMALE
No
Sponsors
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University Hospital Tuebingen
OTHER
Responsible Party
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Principal Investigators
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Sara Y Brucker, MD
Role: PRINCIPAL_INVESTIGATOR
University Women's Hospital, Calwerstrasse 7, 72076 Tübingen, Germany
Locations
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University Women's Hospital
Tübingen, , Germany
Countries
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Other Identifiers
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GFA-001
Identifier Type: -
Identifier Source: org_study_id