Pelvic Organ ProlapseNCT03991455
Evaluation of Safety and Efficacy of the Apyx™ Device for the Repair of Pelvic Organ Prolapse (POP)
A study testing Apyx device in people with Pelvic Organ Prolapse, run by Escala Medical LTD at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Apyx device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteIsrael
- Study dates
- 25 Oct 2019to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Apyx device
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apyx deviceDevice
The Apyx device enables approximation and fixation of the vaginal apex to the SSL using a deployable anchoring system.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Apyx device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (5)
Objective success rate
POP-Q points Ba less than -1 and C less than -½ TVL
Measured: 6 months
Change in PFDI-20
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
Measured: at baseline 3 months, 6 months, and 12 months compared to preoperative
Change in PISQ-12 scores
The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire -12 (PISQ-12) includes question for estimation of sexual function for women with POP urinary incontinence and or fecal incontinence
Measured: at baseline 3 months, 6 months, and 12 months compared to preoperative
PGI-I
Patient Global Impression of Improvement include one question which describes how the patient evaluates the post surgery improvement with a scale of 1 to 7. 1 is very much better and 7 is very much worse
Measured: 3 months, 6 months, and 12 months
Unanticipated Device-related Serious Adverse Event rate
Unanticipated Device-related Serious Adverse Event rate
Measured: at intervals of 2 weeks, 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start25 Oct 2019
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escala Medical LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991455
- Sponsor's protocol ID
- 1806019328
- Status last verified
- Jul 2022
- First submitted
- 17 Jun 2019
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of the Apyx™ Device for the Repair of Pelvic Organ Prolapse (POP)
- ClinicalTrials.gov ID
- NCT03991455
- Acronym / sponsor ID
- 1806019328
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Escala Medical LTDIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apyx device treatment | Other | Device: Apyx deviceThe 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apyx deviceThe Apyx device enables approximation and fixation of the vaginal apex to the SSL using a deployable anchoring system. | Device | Apyx device treatment |
Primary outcome
Change in PFDI-20 Prolapse Subscale (POPDI-6) score
Time frame: 6 months
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
5 secondary outcomes
Objective success rate
Time frame: 6 months
Change in PFDI-20
Time frame: at baseline 3 months, 6 months, and 12 months compared to preoperative
Change in PISQ-12 scores
Time frame: at baseline 3 months, 6 months, and 12 months compared to preoperative
PGI-I
Time frame: 3 months, 6 months, and 12 months
Unanticipated Device-related Serious Adverse Event rate
Time frame: at intervals of 2 weeks, 3 months, 6 months, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apyx device in people with Pelvic Organ Prolapse, run by Escala Medical LTD at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PFDI-20 Prolapse Subscale (POPDI-6) score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.