Preventing Preterm Birth With a Negative Pressure Cervical Cup: a Feasibility Study

Status unconfirmed · Phase 1

Conditions studied: Preterm Birth, Cervical Incompetence, Cervical Insufficiency, Short Cervix, Soft Cervix

In brief

The goal of this Phase I clinical trial is to generate proof-of-concept data to demonstrate that a cervical cup in combination with vacuum application will create negative pressure on uterine cervical tissue, thereby creating immediate cervical stiffness in order to prevent cervical ripening that is associated with spontaneous preterm birth. Aim #1: Conduct a Phase I clinical study. 1A: Evaluate the ability of a cervical cup to improve cervical tissue physiology of uterine cervices in vivo for nonpregnant women. 1B: Evaluate the ability of a cervical cup to be safely placed and removed on uterine cervices in vivo for nonpregnant women.

Key facts

Study ID

NCT05512052

Run by

Galena Innovations, LLC

People needed

40

Starts

2023-04-01

Expected to finish

2024-04-01

Last updated by the study team

2022-08-26

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• women undergoing hysterectomy

You may not qualify if…

• if the candidate has undergone previous cervical surgeries or procedures including cerclage, loop electrosurgical excision procedure (LEEP), or cone biopsy
• has been diagnosed with collagen vascular disease
• a diagnosis of malignant or premalignant cervical changes
• a cervical length less than 15mm or greater than 45mm
• a cervical transverse diameter less than 15mm or greater than 35mm

Where it is running

• Intermountain Utah Valley Hospital — Provo, Utah, United States

Full record on ClinicalTrials.gov

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