Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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. The trial reports 1 study location across 1 state.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02332759
The ClinicalTrials.gov registry entry for NCT02332759 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.