Pregnancy Outcome Following Global Fibroid Ablation Using the Acessa™ System

Not Applicable

Completed

• Conditions: One or More Uterine Fibroids
• Interventions: Device: radiofrequency generator

• Registration Number: NCT03028610
• Lead Sponsor: University Hospital Tuebingen

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2017-01-19
• Study First Posted: 2017-01-23
• Primary Completion: 2023-07-13
• Study Completion: 2023-08-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

Inclusion Criteria

1. Are premenopausal and aged 18 to 40 years.

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

1. Have contraindications for laparoscopic surgery and/or general anesthesia.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acessa™ System	radiofrequency generator	radiofrequency generator

Primary Outcome Measures

Name	Time	Method
Vaginal delivery and either	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	three years	i. Uncomplicated delivery or ii. Delivery with complications such as: * Preterm delivery; * Preterm labor; * Uterine rupture; * Stillbirths; * Postpartum
Spontaneous abortion	6 months
Ectopic pregnancy	three years

Secondary Outcome Measures

Name	Time	Method
Post-treatment readmission and reintervention rate within 1 month post-procedure assessed by questionnairie	1 month
Post-treatment changes in menstrual status up to 36 months post-procedure assessed by a menstrual impact score	three years
Post-treatment changes in myoma size as determined by ultrasound	3, 6, 36 months
Procedure-related complications within 1 month post-procedure	1 month

Trial Locations

Locations (1)

University Women's Hospital; 🇩🇪 Tübingen, Germany