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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01111409




Registration number
NCT01111409
Ethics application status
Date submitted
26/04/2010
Date registered
27/04/2010
Date last updated
13/10/2014

Titles & IDs
Public title
A Pilot Study to Evaluate the Clinical Effectiveness and Safety of the VFIX Device as Treatment for Apical Prolapse
Scientific title
A Prospective, Multi-Centre Pilot Study to Evaluate the Clinical Effectiveness and Safety of the VFIX Device as Treatment for Apical Prolapse
Secondary ID [1] 0 0
300-08-013
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic Organ Prolapse 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - VFIX Device

Experimental: VFIX -


Treatment: Devices: VFIX Device
Sterile, single-use instrument capable of delivering an absorbable PDS suture anchor
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* Age greater than or equal to 18 years
* Subjects of child bearing potential have a negative blood or urine pregnancy test prior to the procedure and subject has completed childbearing
* Subject with apical prolapse at stage II or more and requiring treatment (C should be at least -1 cm)
* On reduction of the apical prolapse, leading edge of prolapse should be at or above the hymen
* If applicable, subject has small/normal size uterus and there is no elongation of the cervix as determined by clinical assessment
* The vaginal apex can reach the Sacrospinous Ligament (SSL) on exam
* Subjects are allowed concurrent incontinence procedure as required
* Concurrent perineal repairs and excision of excess vaginal tissue repairs as required
* Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee approved informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Additional surgical intervention for POP repairs concurrent to the VFIX procedure (including, but not limited to sacrocolpopexy, paravaginal repair, colporrhaphy, mesh repair, etc)
* Experimental drug or experimental medical device within 3 months prior to the planned procedure
* Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
* Previous hysterectomy within 6 months of scheduled surgery.
* Coagulation disorder or on therapeutic anticoagulant therapy (except aspirin) at the time of surgery
* Nursing or pregnant
* Presence of cancers of the vagina, cervix, or uterus
* In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2011
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
QEII Hospital - Brisbane
Recruitment hospital [2] 0 0
Frances Perry House - Parkville
Recruitment hospital [3] 0 0
Urogynaecology Unit, Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
QLD 4108 - Brisbane
Recruitment postcode(s) [2] 0 0
VIC 3052 - Parkville

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ethicon, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this pilot study is to evaluate the safety and effectiveness of the VFIX device in maintaining vaginal apical support for at least 6 months in women with symptomatic apical prolapse (upper vaginal or uterine prolapse).
Trial website
https://clinicaltrials.gov/study/NCT01111409
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Robinson, MD
Address 0 0
Ethicon, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01111409