Pelvic Organ ProlapseNCT02239133
R&D Supporting Pilot Study for the Assessment of the Safety and Effectiveness of the ProVATE (ProTIPI) Vaginal Pessary
A study testing ProVATE vaginal pessary in people with Pelvic Organ Prolapse, run by ConTIPI Medical at 3 sites in Israel.
Trial summary
The study includes five (5) main stages: Screening, Enrollment, Size fitting, Usage and Termination. Subject screening will be held during visit one (1) and visit two (2) at the clinic. Read more about this study
- Who is it for?
- Ages 21 to 80 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- ProVATE vaginal pessary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesIsrael
- Study dates
- Aug 2014to Sep 2016
- 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 21 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females aged 21-80 years
- Ability to use both hands and insert a device into the vagina
- Ability to attend the study site as explained by the investigator
- A symptomatic sensation of vaginal prolapse
- The subject has the ability to understand the nature of the study and sign the informed consent
- On examination, the presence of a vaginal wall prolapse of one or more sites
Show all 9Show fewer
- On examination, POP-Q grade 2 - 4 POP is demonstrated
- A 61-91 mm pessary is well fitted
- A 61-91 mm pessary is well retained
Who cannot join
- Previous inability to accommodate with tampons or vaginal pessaries
- Subject is currently participating in another clinical study which may directly or indirectly affect the results of this study
- Co-morbid condition(s) or severe systemic disease that could limit the subject 's ability to participate in the study, or impact the scientific integrity of the study
- Subject is pregnant, or suspected to be pregnant or is planning to be pregnant during the course of the study
- Abnormal vaginal bleeding in the past 6 months
- Previous vaginal surgery during the last 3 months
Show all 12Show fewer
- A severely atrophic vagina
- Existing vaginal or vulvar laceration
- Symptomatic vaginal infection as determined by physical examination and lab results
- Symptomatic urinary tract infection as determined by physical examination and lab results
- Recurrent urinary tract infections
- Abnormal cervical cytology
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: Pilot Study for the Evaluation of the ProVATE (ProTIPI) Pessary Designs in the Temporary Management of Pelvic Organ Prolapse (POP) in Women
The study includes five (5) main stages: Screening, Enrollment, Size fitting, Usage and Termination.
Subject screening will be held during visit one (1) and visit two (2) at the clinic.
Read more
Initiation and Size fitting:
All eligible subjects will undergo size fitting by a gynecologist / urogynecologist, during visit 2, to find the suitable size for her. The subject will use the ProVATE device of the chosen size at the clinic vicinity for about one (1) hour and for 40-80 hours at her home environment, to confirm that the chosen size is appropriate for the user. Each usage will be followed by a vaginal examination. In case the investigator will determine that the subject should be fitted with a different size of the ProVATE device the subject will repeat this stage with a different device size until the suitable size is confirmed by the investigator.
Usage:
The subject will use the ProVATE device for at least 28 days during a 45 days period, at her home environment, and fill a usage diary. Each device will be used for at least 24 hours. At least one (1) follow-up phone call will be held with the subject per a week. After 14 usage days or following at least two (2) usages (the latest of them) the subject will be scheduled for vaginal examination at the clinic (visit four (4)).
End Of Use At the end of use the subject will return to the clinic (visit five (5)) for a vaginal examination and additional activities.
The following questionnaires will be filled at baseline and end of study: Quality Of Life (QoL) and POP symptoms. Satisfaction and Ease Of Use questionnaires will be filled at the end of use (visit 5) Up to four (4) ProVATE device models will be tested in this study.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- ProVATE vaginal pessary
- Keywords
- Pelvic Organ Prolapse, POP
- 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.
ProVATE vaginal pessaryDevice
| Study group | Role | What they receive |
|---|---|---|
| ProVATE vaginal pessary | Experimental | The ProVATE device is a disposable, single-use, vaginal pessary for the management of Pelvic Organ Prolapse ("POP"). The ProVATE device is similar to other ring pessaries currently on the market. Its features allow for easy and comfortable insertion and removal by the user herself at her home environment. The ProVATE device is provided in six (6) different sizes and is intended for prescription use only. Receives: Device: ProVATE vaginal pessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of prolapse and POP symptoms following ProVATE device insertion, compared to the degree of prolapse prior to the insertion of the ProVATE device (by vaginal examination)
Measured: At day 1 - baseline, and following at least 28 and up to 45 days of using the ProVATE vaginal pessary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConTIPI Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239133
- Sponsor's protocol ID
- ProVATE PT 103
- Status last verified
- Dec 2015
- First submitted
- 8 Sep 2014
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Evaluation of the ProVATE (ProTIPI) Pessary Designs in the Temporary Management of Pelvic Organ Prolapse (POP) in Women
- ClinicalTrials.gov ID
- NCT02239133
- Acronym / sponsor ID
- ProVATE PT 103
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pelvic Organ Prolapse, POP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (actual)
- Lead sponsor
- ConTIPI MedicalIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 12 Sep 2014 (estimated)
- 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 study includes five (5) main stages: Screening, Enrollment, Size fitting, Usage and Termination.
Subject screening will be held during visit one (1) and visit two (2) at the clinic.
Initiation and Size fitting:
All eligible subjects will undergo size fitting by a gynecologist / urogynecologist, during visit 2, to find the suitable size for her. The subject will use the ProVATE device of the chosen size at the clinic vicinity for about one (1) hour and for 40-80 hours at her home environment, to confirm that the chosen size is appropriate for the user. Each usage will be followed by a vaginal examination. In case the investigator will determine that the subject should be fitted with a different size of the ProVATE device the subject will repeat this stage with a different device size until the suitable size is confirmed by the investigator.
Usage:
The subject will use the ProVATE device for at least 28 days during a 45 days period, at her home environment, and fill a usage diary. Each device will be used for at least 24 hours. At least one (1) follow-up phone call will be held with the subject per a week. After 14 usage days or following at least two (2) usages (the latest of them) the subject will be scheduled for vaginal examination at the clinic (visit four (4)).
End Of Use At the end of use the subject will return to the clinic (visit five (5)) for a vaginal examination and additional activities.
The following questionnaires will be filled at baseline and end of study: Quality Of Life (QoL) and POP symptoms. Satisfaction and Ease Of Use questionnaires will be filled at the end of use (visit 5) Up to four (4) ProVATE device models will be tested in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ProVATE vaginal pessary | Experimental | Device: ProVATE vaginal pessaryThe ProVATE device is a disposable, single-use, vaginal pessary for the management of Pelvic Organ Prolapse ("POP"). The ProVATE device is similar to other ring pessaries currently on the market. Its features allow for easy and comfortable insertion and removal by the user herself at her home environment. The ProVATE device is provided in six (6) different sizes and is intended for prescription use only. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Females aged 21-80 years
- Ability to use both hands and insert a device into the vagina
- Ability to attend the study site as explained by the investigator
- A symptomatic sensation of vaginal prolapse
- The subject has the ability to understand the nature of the study and sign the informed consent
Key exclusion criteria (12 listed)
- Previous inability to accommodate with tampons or vaginal pessaries
- Subject is currently participating in another clinical study which may directly or indirectly affect the results of this study
- Co-morbid condition(s) or severe systemic disease that could limit the subject 's ability to participate in the study, or impact the scientific integrity of the study
- Subject is pregnant, or suspected to be pregnant or is planning to be pregnant during the course of the study
- Abnormal vaginal bleeding in the past 6 months
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 |
|---|---|---|
| ProVATE vaginal pessary | Device | ProVATE vaginal pessary |
Primary outcome
Degree of prolapse and POP symptoms following ProVATE device insertion, compared to the degree of prolapse prior to the insertion of the ProVATE device (by vaginal examination)
Time frame: At day 1 - baseline, and following at least 28 and up to 45 days of using the ProVATE vaginal pessary
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
Related trials for Pelvic Organ Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Not yet recruitingPhase 4
Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management
Pelvic Organ Prolapse (POP), Postoperative Pain
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProVATE vaginal pessary in people with Pelvic Organ Prolapse, run by ConTIPI Medical at 3 sites 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 9 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 31 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
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?
Degree of prolapse and POP symptoms following ProVATE device insertion, compared to the degree of prolapse prior to the insertion of the ProVATE device (by vaginal examination) (time frame: At day 1 - baseline, and following at least 28 and up to 45 days of using the ProVATE vaginal pessary). 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 31 Dec 2015.