Status:
UNKNOWN
R&D Supporting Pilot Study for the Assessment of the Safety and Effectiveness of the ProVATE (ProTIPI) Vaginal Pessary
Lead Sponsor:
ConTIPI Medical
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
21-80 years
Phase:
NA
Brief 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. Initiation a...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT02239133
Start Date
August 1 2014
End Date
September 1 2016
Last Update
December 31 2015
Active Locations (3)
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1
Site 01
Herzliya, Israel
2
Site 02
Herzliya, Israel
3
Site 03
Ramat HaSharon, Israel