Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions

NCT ID: NCT01750008

Last Updated: 2018-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2018-06-30

Brief Summary

The purpose of this study is to compare the outcomes of two uterine-conserving treatment alternatives for symptomatic uterine fibroids: laparoscopic myomectomy (LM) and global fibroid ablation (GFA) using the Halt System. Laparoscopic ultrasound (LUS) is a standard step prior to the GFA procedure but has not been a standard step prior to LM. Incorporating laparoscopic ultrasound as a first step prior to both treatments allows the surgeon to have equal access to valuable imaging information and to plan treatment accordingly. By randomizing the subject immediately after laparoscopic ultrasound, selection bias toward one treatment or the other following the LUS is eliminated.

Conditions

Uterine Fibroids; Myomas

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Global Fibroid Ablation

Global Fibroid Ablation

Group Type: OTHER

Global Fibroid Ablation

Intervention Type: PROCEDURE

Laparoscopic Myomectomy

Myomectomy via laparoscopy

Group Type: OTHER

Myomectomy

Intervention Type: PROCEDURE

Interventions

Global Fibroid Ablation

Intervention Type: PROCEDURE

Myomectomy

Intervention Type: PROCEDURE

Other Intervention Names

Halt Procedure; Acessa Procedure

Eligibility Criteria

Inclusion Criteria

• Are ≥ 18 years old and menstruating
• Have symptomatic uterine fibroids
• Have a uterine size ≤16 gestational weeks as determined by pelvic exam
• Have fibroids that are less than 10 cm in any diameter
• Desire uterine conservation
• Have had a normal Papanicolaou test (PAP smear) (i.e. PAP I or PAP II) at the latest pre-study examination and no longer than 36 months before study entry.
• Are willing and able to comply with all study tests, procedures, and assessment tools
• Are capable of providing informed consent.

Exclusion Criteria

• Have contraindications for laparoscopic surgery and/or general anesthesia.
• Are expected to be high risk for, or are known to have, significant intra-abdominal adhesions (defined as adhesions that would require extensive dissection to mobilize and view all surfaces of the uterus)
• Patients requiring major elective concomitant procedures (e.g., hernia repair, hysteroscopic resection, endometrial ablation, uterine artery ligation, etc.) that could confound the results of the study
• Are pregnant or lactating
• Have taken any depot Gonadotropin-releasing hormone (GnRh agonist within three months prior to the screening procedures
• Have an implanted intrauterine or fallopian tube device for contraception that cannot or will not be removed at least ten days prior to treatment
• Have chronic pelvic pain not due to uterine fibroids
• Have known or suspected endometriosis or 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 non-uterine pelvic mass over 3 cm
• Have a cervical myoma
• Have one or more completely intracavitary submucous fibroids (Type 0) or only Type 0/1 submucous fibroids that are better treated via hysteroscopic methods
• In the medical judgment of the investigator should not participate in the study
• Are not willing to be randomized to treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Acessa Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sara Brucker, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tubingen

Locations

Tubingen University Hospital

Tübingen, , Germany

Countries

Germany

References

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Other Identifiers

CP-00-0018

Identifier Type: -

Identifier Source: org_study_id