NCT03991455

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

October 25, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

2.5 years

First QC Date

June 17, 2019

Last Update Submit

July 26, 2022

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

  • Change in PFDI-20 Prolapse Subscale (POPDI-6) score

    Pelvic Floor Disability Index (PFDI-20) includes 20 questions are rated from 0 to 4, with 0 is no present of distress and 4 is the highest of symptom scale. Pelvic Floor Disability Index distress index is a subscale of the first 6 questions of the above scale

    6 months

Secondary Outcomes (5)

  • Objective success rate

    6 months

  • Change in PFDI-20

    at baseline 3 months, 6 months, and 12 months compared to preoperative

  • Change in PISQ-12 scores

    at baseline 3 months, 6 months, and 12 months compared to preoperative

  • PGI-I

    3 months, 6 months, and 12 months

  • Unanticipated Device-related Serious Adverse Event rate

    at intervals of 2 weeks, 3 months, 6 months, and 12 months

Study Arms (1)

Apyx device treatment

OTHER

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.

Device: Apyx device

Interventions

Apyx deviceDEVICE

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

Apyx device treatment

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen with Stage 2-4 apical prolapse who desire uterine preservation.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical Center

Haifa, 3109601, Israel

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2019

First Posted

June 19, 2019

Study Start

October 25, 2019

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

July 27, 2022

Record last verified: 2022-07

Locations

IL(1)