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

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

Interventions

DEVICE

Hannah Cervical Cup (2 mm Delta)

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.

DEVICE

Hannah Cervical Cup (4 mm Delta)

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.

DEVICE

Hannah Cervical Cup (6 mm Delta)

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.

Sponsors & Collaborators

• Galena Innovations, LLC

  lead INDUSTRY

Principal Investigators

• Ashley C Crafton · Galena Innovations

Study Design

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-04-30

Primary Completion

2024-04-30

Completion

2024-04-30

FDA Device

Yes

Countries

• United States

Study Locations