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NCT02332759 · ClinicalTrials.gov registry record · NA
A Pilot Study To Evaluate The Preliminary Safety And Feasibility Of The Materna Medical Device
A NA study of Tear, Pelvic Organ, Obstetric Trauma, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 61
- Enrollment target
- 1
- Study location
NCT02332759: Completed NA study of Tear, Pelvic Organ, Obstetric Trauma, sponsored by Baylor College of Medicine.
NCT02332759 is a NA study of Tear, Pelvic Organ, Obstetric Trauma that has completed, run by Baylor College of Medicine. The registered enrollment target is 61 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
NCT02332759, a NA study of Tear, Pelvic Organ, Obstetric Trauma, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 61 participants
- Enrollment target
- 1
- Study location
Study Summary
The Materna device aims to prevent pelvic tissue damage by preventing overstretching of pelvic floor muscle fibers during delivery. The device is a single use, disposable, mechanical dilator that penetrates the first 4 cm or ½ of the vaginal canal and gradually expands the vagina from a resting diameter of 2-3 cm to the fully expanded size of a delivering fetus, roughly 8-10 cm. The Materna device will be used during the first stage of labor, for roughly 1-2 hours, in a hospital Labor and Delivery unit, under the supervision of trained clinical labor and delivery providers
Conditions Studied
Interventions
- DEVICE Materna Medical
Study Locations (1)
Texas
- Texas Children's Hospital Pavilion For Women - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2014-07 |
| Est. Completion | 2016-12 |
| Phase | NA |
What the finished NCT02332759 record still lists
NCT02332759 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 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 Tear, Pelvic Organ, Obstetric Trauma appearing as the primary indexed condition, and to 1 intervention - of which Materna Medical is the first listed.
NCT02332759 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02332759 about?
NCT02332759 is a clinical study titled "A Pilot Study To Evaluate The Preliminary Safety And Feasibility Of The Materna Medical Device". The Materna device aims to prevent pelvic tissue damage by preventing overstretching of pelvic floor muscle fibers during delivery. The device is a single use, disposable, mechanical dilator that penetrates the first 4 cm or ½ of the vaginal canal and gradually expands the vagina from a resting diam...
What is the current status of trial NCT02332759?
This trial is currently completed. It is a NA study. The enrollment target is 61 participants. The study started on 2014-07. Estimated completion is 2016-12.
What conditions does trial NCT02332759 study?
This clinical trial studies the following conditions: Tear, Pelvic Organ, Obstetric Trauma.
What interventions are being tested in trial NCT02332759?
The interventions under investigation include: Materna Medical (DEVICE).
Who is sponsoring clinical trial NCT02332759?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02332759 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02332759's enrollment target sits among peer trials
61 1164th of 2000 higher than 837 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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