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Poster Session 4

Category: Prematurity

Poster Session 4

(1212) First-In-Human Study of a Novel Medical Device In PPROM

Thursday, February 12, 2026

3:30 PM - 5:00 PM

Submitting Author(s)

Kathryn D. Wine, MPH (she/her/hers)

Vice President of Clinical Affairs
Novocuff, Inc.
Danville, California, United States

Coauthor(s)

RM

Ross McQuivey, MD

Novocuff, Inc.
Mountain View, California, United States

Presenting Author(s)

Osvaldo Reyes, MD

Hospital Santo Tomas
Panama City, Panama, Panama

Objective:
Preterm prelabor rupture of membranes (PPROM) is associated with significant maternal and neonatal morbidity and mortality and therapeutic options are limited. Safety and feasibility of the investigational Novocuff Cervical Control System (CCS) for the treatment of PPROM were evaluated.

Study Design:
A prospective, single-arm study of the Novocuff CCS was completed at a single center in Panama from September 2023 to March 2024. Gravidas aged ≥ 18 years, with PPROM between 24-34 weeks gestational age (GA), were eligible. Exclusions included suspected intra-amniotic infection (IAI), signs of labor, vaginal bleeding, cervical length < 15mm, cervical dilation > 1cm, and untreated pelvic/vaginal infection. After ≥ 48 hours of PPROM, eligible gravidas were consented and treated with the Novocuff CCS until up to 34 weeks GA. Standard PPROM expectant management, including corticosteroids and latency antibiotics, were provided. The primary outcome was a composite safety measure, including IAI within 1 week of device placement, chorioamnionitis, and device-related cervicovaginal injury. Secondary outcomes included latency, amniotic fluid index (AFI) measurements, and participant/investigator satisfaction. Participants and their infants were followed until hospital discharge, with a 2-week postpartum follow-up visit. Descriptive statistics were used to present outcomes.

Results:
Thirteen gravidas met study criteria (Table 1) and the device was successfully placed in every case. The primary endpoint success rate was 100%, with no IAI, chorioamnionitis or cervicovaginal injury. The mean PPROM latency was 24.08 days (median 17.0, min 8, max 65 days, Figure 1). AFI returned to normal from oligohydramnios or remained normal in all cases where AFI was measured post-device placement. The investigator reported the device easy to use, and all participants reported they would use it again.

Conclusion:
Results provide preliminary evidence that the Novocuff CCS is feasible and safe, with potential effectiveness in PPROM management. A larger comparative study is warranted.