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

NCT05512052 | Unknown Phase 1 FDA Device

• 1 other identifier: 1A
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm Birth; Cervical Incompetence; Cervical Insufficiency; Short Cervix; Soft Cervix

Keywords

Cervix

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety: incidence (in number) of Treatment-Related Adverse Events

  1 month

Study Arms (3)

Hannah Cervical Cup (2 mm)

EXPERIMENTAL

Device: Hannah Cervical Cup (2 mm Delta)

Hannah Cervical Cup (4 mm)

EXPERIMENTAL

Device: Hannah Cervical Cup (4 mm Delta)

Hannah Cervical Cup (6 mm)

EXPERIMENTAL

Device: Hannah Cervical Cup (6 mm Delta)

Interventions

Hannah Cervical Cup (2 mm Delta) DEVICE

The Hannah Cervical Cup reverses and prevents early cervical change by improving cervical collagen function. It applies negative pressure to the cervix, placing it in a tensile strain. Collagen under tension elicits fibers to realign, creating initial stiffness. This enables the cervix to remain closed. Over time, the extracellular matrix becomes strengthened as tension increases collagen strength and synthesis, and decreases degradation and adhesions. It also decreases prostaglandins--inflammatory mediators that facilitate birth. The Hannah Cervical Cup will create stiffness and length in the cervix, provide a treatment for early rupture of fetal membranes, and will offer a mode of medication administration. It is simple in nature, non-invasive, may be used in low-income, low-resource settings, can be placed by a physician in inpatient and outpatient settings, and does not require anesthesia during placement. The Hannah Cervical Cup (2 mm Delta) displaces the cervical tissue by 2 mm.

Hannah Cervical Cup (2 mm)

Hannah Cervical Cup (4 mm Delta) DEVICE

The Hannah Cervical Cup reverses and prevents early cervical change by improving cervical collagen function. It applies negative pressure to the cervix, placing it in a tensile strain. Collagen under tension elicits fibers to realign, creating initial stiffness. This enables the cervix to remain closed. Over time, the extracellular matrix becomes strengthened as tension increases collagen strength and synthesis, and decreases degradation and adhesions. It also decreases prostaglandins--inflammatory mediators that facilitate birth. The Hannah Cervical Cup will create stiffness and length in the cervix, provide a treatment for early rupture of fetal membranes, and will offer a mode of medication administration. It is simple in nature, non-invasive, may be used in low-income, low-resource settings, can be placed by a physician in inpatient and outpatient settings, and does not require anesthesia during placement. The Hannah Cervical Cup (4 mm Delta) displaces the cervical tissue by 4 mm.

Hannah Cervical Cup (4 mm)

Hannah Cervical Cup (6 mm Delta) DEVICE

The Hannah Cervical Cup reverses and prevents early cervical change by improving cervical collagen function. It applies negative pressure to the cervix, placing it in a tensile strain. Collagen under tension elicits fibers to realign, creating initial stiffness. This enables the cervix to remain closed. Over time, the extracellular matrix becomes strengthened as tension increases collagen strength and synthesis, and decreases degradation and adhesions. It also decreases prostaglandins--inflammatory mediators that facilitate birth. The Hannah Cervical Cup will create stiffness and length in the cervix, provide a treatment for early rupture of fetal membranes, and will offer a mode of medication administration. It is simple in nature, non-invasive, may be used in low-income, low-resource settings, can be placed by a physician in inpatient and outpatient settings, and does not require anesthesia during placement. The Hannah Cervical Cup (6 mm Delta) displaces the cervical tissue by 6 mm.

Hannah Cervical Cup (6 mm)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: This clinical trial focuses on increasing cervical stiffness in order to prevent spontaneous preterm birth. Biologically identified women of a reproductive age are eligible.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Galena Innovations, LLC: lead

Study Sites (1)

Intermountain Utah Valley Hospital

Provo, Utah, 84604, United States

Location

MeSH Terms

Conditions

Premature Birth; Uterine Cervical Incompetence

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Abortion, Habitual; Abortion, Spontaneous; Genital Diseases

Study Officials

• Ashley C Crafton

  Galena Innovations

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley C Crafton

CONTACT

208-870-0904; ashley@galenainnovations.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 23, 2022
• Study Start: April 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)