Status and phase
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About
This study is to determine whether intrauterine instillation of Juveena hydrogel following adhesiogenic hysteroscopic procedures (TCGP + Juveena) can safely and effectively reduce the incidence and severity of intrauterine adhesions (IUA) compared to TCGP alone.
Full description
This is a prospective, multicenter, randomized controlled subject and evaluator-blinded pivotal study to investigate the safety and effectiveness of the Juveena Hydrogel System when used to reduce the occurrence of IUA in women undergoing TCGPs associated with a high prevalence of post-procedural IUA (i.e., adhesiolysis for moderate to severe adhesions or myomectomy of multiple or large myoma). A second look hysteroscopy (SLH) will be performed at the Week 8 visit to evaluate the presence and severity of IUA.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Premenopausal
Candidate for one of the following hysteroscopic procedures:
Subject agrees to all protocol requirements including returning for specified visits within intervals identified within this protocol.
Subject is willing to undergo an SLH at the Week 8 visit.
Subject agrees to abstain from sexual intercourse or use a reliable form of barrier contraception following the study procedure through the Week 8 visit.
Subject has signed the IRB/EC approved informed consent
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
150 participants in 2 patient groups
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Central trial contact
Ian Feldberg; Jonathan Bissett
Data sourced from clinicaltrials.gov
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