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NCT07200115 · ClinicalTrials.gov registry record · NA
RCT of Cervical Ripening Double Ballon Catheter Prior to Dilation and Evacuation.
A NA study of Cervical Preparation Prior to Dilation and Evacuation, sponsored by Yale University.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT07200115 is a NA study of Cervical Preparation Prior to Dilation and Evacuation that is actively recruiting participants, run by Yale University. The registered enrollment target is 50 participants. The trial reports 1 study location across 1 state.
The verdict
NCT07200115, a NA study of Cervical Preparation Prior to Dilation and Evacuation, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine whether the overnight use of an FDA-cleared CRDB catheter is superior to the use of overnight osmotic dilators as is standard of care cervical preparation for patients presenting for dilation and evacuation (D\&E). The CRDB catheter is an FDA cleared device for cervical dilation prior to labor induction at term. It has not been FDA cleared for cervical dilation in the second-trimester, however, will be used in a similar fashion to labor inductions at term. Our standard of care osmotic dilators (e.g., laminaria, Dilapan-S) are both FDA cleared for cervical dilation prior to labor induction at term or gynecologic procedures requiring cervical dilation.
Conditions Studied
Interventions
- DEVICE Cervical Ripening Double Balloon (CRDB) Catheter
- DEVICE Osmotic Dilators
Study Locations (1)
Connecticut
- Yale Family Planning Clinic - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-12-03 |
| Est. Completion | 2028-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07200115
The ClinicalTrials.gov registry entry for NCT07200115 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cervical Preparation Prior to Dilation and Evacuation appearing as the primary indexed condition, and to 2 interventions - of which Cervical Ripening Double Balloon (CRDB) Catheter is the first listed.
NCT07200115 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.
Frequently Asked Questions
What is clinical trial NCT07200115 about?
NCT07200115 is a clinical study titled "RCT of Cervical Ripening Double Ballon Catheter Prior to Dilation and Evacuation.". The purpose of this study is to determine whether the overnight use of an FDA-cleared CRDB catheter is superior to the use of overnight osmotic dilators as is standard of care cervical preparation for patients presenting for dilation and evacuation (D\&E). The CRDB catheter is an FDA cleared device ...
What is the current status of trial NCT07200115?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2025-12-03. Estimated completion is 2028-09.
What conditions does trial NCT07200115 study?
This clinical trial studies the following conditions: Cervical Preparation Prior to Dilation and Evacuation.
What interventions are being tested in trial NCT07200115?
The interventions under investigation include: Cervical Ripening Double Balloon (CRDB) Catheter (DEVICE), Osmotic Dilators (DEVICE).
Who is sponsoring clinical trial NCT07200115?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07200115 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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