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NCT04365465 · ClinicalTrials.gov registry record · NA
BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control
A NA study of Opioid Use Disorder and Pain, Postoperative, sponsored by Grace Lim, MD, MS.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04365465: Completed NA study of Opioid Use Disorder and Pain, Postoperative, sponsored by Grace Lim, MD, MS.
NCT04365465 is a NA study of Opioid Use Disorder and Pain, Postoperative that has completed, run by Grace Lim, MD, MS. The registered enrollment target is 60 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04365465, a NA study of Opioid Use Disorder and Pain, Postoperative, has completed, sponsored by Grace Lim, MD, MS.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, placebo controlled and natural-history controlled trial to investigate the effectiveness of NSS-2 BRIDGE® for postpartum women with AND without opioid use disorder (OUD). The purpose of this pilot investigation is to establish feasibility/acceptability of the trial design.
Primary Outcome
Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
Conditions Studied
Interventions
- OTHER Active control
- DEVICE NSS-2 Bridge
- DEVICE Inactive NSS-2 Bridge
Study Locations (1)
Pennsylvania
- UPMC Magee Womens Hospital - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-08-17 |
| Est. Completion | 2021-06-30 |
| Phase | NA |
What the finished NCT04365465 record still lists
NCT04365465 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 3 interventions - of which Active control is the first listed.
NCT04365465 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04365465 about?
NCT04365465 is a clinical study titled "BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control". This is a randomized, placebo controlled and natural-history controlled trial to investigate the effectiveness of NSS-2 BRIDGE® for postpartum women with AND without opioid use disorder (OUD). The purpose of this pilot investigation is to establish feasibility/acceptability of the trial design.
What is the current status of trial NCT04365465?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2020-08-17. Estimated completion is 2021-06-30.
What conditions does trial NCT04365465 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Pain, Postoperative.
What interventions are being tested in trial NCT04365465?
The interventions under investigation include: Active control (OTHER), NSS-2 Bridge (DEVICE), Inactive NSS-2 Bridge (DEVICE).
Who is sponsoring clinical trial NCT04365465?
This trial is sponsored by Grace Lim, MD, MS, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04365465 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04365465's enrollment target sits among peer trials
60 156th of 257 higher than 91 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder 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.
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