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Cervical Cup

Negative Pressure Cervical Cup for Preventing Premature Birth

Phase 1

Waitlist Available

Led By Ashley C Crafton

Research Sponsored by Galena Innovations, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

Study Summary

This trial will help researchers learn if a cervical cup can help prevent cervical ripening, which may lead to spontaneous preterm birth.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include discomfort during placement or removal of the cup, possible irritation or injury to cervical tissue from the device itself, and reactions to creating negative pressure on the cervix.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility: increases in cervical stiffness (in SWS m s-1) with cup and pressure application

Secondary outcome measures

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

Trial Design

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

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Galena Innovations, LLCLead Sponsor

Ashley C CraftonPrincipal InvestigatorGalena Innovations

Media Library

Hannah Cervical Cup (2 mm Delta) (Cervical Cup) Clinical Trial Eligibility Overview. Trial Name: NCT05512052 — Phase 1

Cervical Insufficiency Research Study Groups: Hannah Cervical Cup (4 mm), Hannah Cervical Cup (6 mm), Hannah Cervical Cup (2 mm)

Cervical Insufficiency Clinical Trial 2023: Hannah Cervical Cup (2 mm Delta) Highlights & Side Effects. Trial Name: NCT05512052 — Phase 1

Hannah Cervical Cup (2 mm Delta) (Cervical Cup) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05512052 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research trial include adults of legal age?

"The requirements for participation in this trial limit the age of potential patients to between 18 and 50. There are 184 trials that accept children below the age of majority and 75 studies designed specifically for elderly people."

Answered by AI

Has the Hannah Cervical Cup (2 mm Delta) been sanctioned by the FDA?

"With only limited data on safety and efficacy, it is assessed that the Hannah Cervical Cup (2 mm Delta) has a safety rating of 1."

Answered by AI

What criteria must be met in order to participate in this clinical research?

"To qualify for the trial, participants must have a cervical incompetence diagnosis and be within 18-50 years of age. Approximately 40 individuals will be accepted into this study."

Answered by AI

Is recruitment still open for participation in this research?

"Per the records held on clinicaltrials.gov, this trial is not actively enrolling participants at this time. The original posting was made on April 1st 2023 and updated most recently in August 24th 2022. However, 263 other trials are currently looking for patients to participate in research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Preventing Preterm Birth With a Negative Pressure Cervical Cup: a Feasibility Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05512052.