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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: Recruiting NA study of Cervical Preparation Prior to Dilation and Evacuation, sponsored by Yale University.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cervical dilation will be measured in centimeters.
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 |
What NCT07200115 shows while recruiting
NCT07200115 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07200115's enrollment target sits among peer trials
50 1280th of 2000 higher than 622 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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