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Bridge Device for Surgical Pain for Rotator Cuff Surgery

NCT06071884 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-01-14

Study results available
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Summary

The objective of the trial is to investigate the efficacy of the Bridge device in reducing post-operative pain and post-operative opioid consumption in patients undergoing rotator cuff surgery with the typical mode of anesthesia, nerve block plus propofol sedation.

Conditions

  • Pain
  • Rotator Cuff Injuries

Interventions

DEVICE

Bridge Percutaneous Nerve Field Stimulator

The Bridge device is an FDA-cleared, drug-free, non-surgical device that uses neuro-modulation to aid in the reduction of symptoms associated with opioid withdrawal through application to branches of the Cranial Nerves V, VII, IX, X, and the occipital nerves. This study is investigating its effectiveness treating post-surgical pain.

Sponsors & Collaborators

  • Masimo Corporation

    collaborator INDUSTRY

  • Steven Orebaugh

    lead OTHER

Principal Investigators

  • Steven L Orebaugh, MD · University of Pittsburgh

  • Amy Monroe, MPH, MBA · University of Pittsburgh

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-29
Primary Completion
2024-09-26
Completion
2024-09-26
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06071884 on ClinicalTrials.gov