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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
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
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with cervical cancer or precancerous cervical conditions.I am a woman scheduled for a hysterectomy.I have had surgery or procedures on my cervix, like cerclage, LEEP, or a cone biopsy.I have been diagnosed with a collagen vascular disease.
Research Study Groups:
This trial has the following groups:- Group 1: Hannah Cervical Cup (4 mm)
- Group 2: Hannah Cervical Cup (6 mm)
- Group 3: Hannah Cervical Cup (2 mm)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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