Evaluation of Safety and Efficacy of the Apyx™ Device for the Repair of Pelvic Organ Prolapse (POP)

NCT ID: NCT03991455

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-25
• Study Completion Date: 2022-05-01

Brief Summary

The aim of this study is to further evaluate this minimally invasive SSLF technique with respect to safety, clinical effectiveness, and patient satisfaction. The procedure will be performed in women electing to undergo surgical repair of their prolapse who wish to preserve their uterus, and will be evaluated using standardized measures and questionnaires.

Detailed Description

This study will evaluate sacrospinous ligament fixation using an incision-free technique - a technique that was developed with the goal of offering a technically simple, safe, and effective alternative to surgical prolapse repair procedures. When compared to previously reported SSLF methods, this technique has undergone novel modifications with the intent of maximizing efficacy and minimizing invasiveness. First, each sacrospinous ligament is approached trans-vaginally using a small diameter, low profile needle as the delivery platform for the anchoring unit. Secondly, the suspension is bilateral, thus maintaining vaginal length and width without deviation or narrowing of the vagina as might occur with a traditional (unilateral) sacrospinous repair. And third, using bio-degradable sutures and a securing element that stabilizes the fixation as opposed to performing an incision in the vaginal wall for suturing enables an incision-free procedure leaving the vagina free of any device after a period of several weeks.

Conditions

Pelvic Organ Prolapse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apyx device treatment

The Apyx device enables approximation and fixation of the vaginal apex to the SSL using a deployable anchoring system. Using the device, SSLF can be performed transvaginally without the need for any incisions or blind dissections and without the requirement of heavy anesthesia.

Group Type: OTHER

Apyx device

Intervention Type: DEVICE

The Apyx device enables approximation and fixation of the vaginal apex to the SSL using a deployable anchoring system.

Interventions

Apyx device

The Apyx device enables approximation and fixation of the vaginal apex to the SSL using a deployable anchoring system.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Women with prolapse electing to undergo reconstructive vaginal surgery for primary uterovaginal prolapse, who wish to enroll in this trial of an incision-free prolapse repair technique, after being familiarized with the suspected benefits and risks of the procedure.

• Ages 18-90 years old
• POP-Q Stage 2 or greater with an apical support defect, also defined as uterovaginal prolapse
• Desire of uterine preservation
• Patient is willing to return for follow-up evaluation and questionnaire completion at 3 months, 6 months, and 12 months, in addition to routine postoperative standard of care.
• English fluency

Exclusion Criteria

• Previous vaginal, abdominal, or laparoscopic repair for pelvic organ prolapse
• Prior hysterectomy
• Known allergy to Nitinol / Stainless Steel / Polydioxanone.
• Suspected uterine pathology, including malignancy.
• History of chronic pelvic pain, interstitial cystitis or fibromyalgia.
• Women diagnosed with symptomatic uterine fibroids, cervical elongation or hypertrophy, abnormal uterine or vaginal bleeding.
• History of Pelvic Inflammatory Disease (PID)
• Prior pelvic radiation therapy or malignancy.
• Diagnosis of reproductive tract anomalies.
• Pregnant or lactating women.
• Participation in another trial
• Inability to provide informed consent for study enrollment
• PI's subjective assessment that study procedure will not plausibly correct patient pelvic organ prolapse symptoms due to anatomic considerations

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Escala Medical LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rambam Medical Center

Haifa, , Israel

Countries

Israel

Other Identifiers

1806019328

Identifier Type: -

Identifier Source: org_study_id