Negative Pressure Cervical Cup for Preventing Premature Birth

Palo Alto (17 mi)

Overseen byAshley C Crafton

Age: 18 - 65

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Galena Innovations, LLC

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for women who are scheduled to have a hysterectomy and do not have malignant cervical changes, a very short or long cervix, an unusually narrow or wide cervix, history of certain cervical surgeries like cerclage or LEEP, or collagen vascular disease.

Treatment Details

The study tests the Hannah Cervical Cup's ability to stiffen the cervix using negative pressure. This could prevent premature birth by stopping early cervical ripening. There are three versions of the cup with different pressure levels being tested.

3Treatment groups

Experimental Treatment

Group I: Hannah Cervical Cup (6 mm)Experimental Treatment1 Intervention

Group II: Hannah Cervical Cup (4 mm)Experimental Treatment1 Intervention

Group III: Hannah Cervical Cup (2 mm)Experimental Treatment1 Intervention