Preterm Birth Clinical Trial
Official title:
Preventing Preterm Birth With a Negative Pressure Cervical Cup: a Feasibility Study
NCT number | NCT05512052 |
Other study ID # | 1A |
Secondary ID | |
Status | Not yet recruiting |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | April 2023 |
Est. completion date | April 2024 |
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | April 2024 |
Est. primary completion date | April 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - women undergoing hysterectomy Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Intermountain Utah Valley Hospital | Provo | Utah |
Lead Sponsor | Collaborator |
---|---|
Galena Innovations, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility: increases in cervical stiffness (in SWS m s-1) with cup and pressure application | Cervical stiffness with application of the cup and pressure combination ('cup SWS' measured in m s-1) will be measured and compared to cervical stiffness prior to application ('baseline SWS' measured in m s-1) to determine the significance of the change in stiffness. | 15-30 minutes | |
Secondary | Safety: incidence (in number) of Treatment-Related Adverse Events | Measure the incidence (in number) of the following Treatment-Related Adverse Events:
bleeding contusions infection abrasions tearing |
1 month |
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