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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
150
Application of a novel hydrogel immediately following the transcervical procedure
Arizona Gynecology Consultants
Phoenix, Arizona, United States
UCSF Center for Reproductive Health
San Francisco, California, United States
Freedom from intrauterine adhesions (IUA)
Incidence of No IUA at second look hysteroscopy (SLH)
Time frame: 8 weeks
Severity of IUA
Severity of IUA classified according to March criteria at SLH
Time frame: 8 weeks
Freedom of IUA with superiority margin of 5% over control at IUA
Incidence of No IUA with superiority margin of 5% over control
Time frame: 8 weeks
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