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Evaluate the Safety and Efficacy of a Peripheral Nerve Stimulation

NCT05827848 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2024-06-28

No results posted yet for this study

Summary

This trial was conducted in a prospective, multicenter, randomized withdrawal design at a designated clinical trial facility. The total sample size for this trial is expected to be 59-62 patients.

One to two subjects were conducted in each study center as a preliminary test. A total of about 3-6 subjects were selected for the pre-test. The pre-test subjects used the test equipment (on state) and were not randomized.

The study was divided into screening/baseline period, treatment period (including test period, random withdrawal period and observation period) and follow-up period.

All subjects underwent a 7-day baseline assessment (VAS score for at least 4 days) during the screening/baseline period. Eligible subjects underwent Peripheral Nerve Stimulation(PNS) surgery and implanted electrode leads and entered the 7-day test period. During the test period, subjects with an average VAS score improvement of ≥30%(VAS score for at least 4 days) will be randomly assigned to the experimental group (on state) or the control group (off state) in a 1:1 ratio for 7 days observation. All subjects were enrolled in the observation period until 28 days after implantation. Safety assessment was performed at a 14-day follow-up after removal of the device.

Conditions

  • Complications; Prosthesis, Nervous System, Peripheral, Pain

Interventions

DEVICE

Percutaneous peripheral nerve stimulation system

All subjects underwent a 7-day baseline assessment (VAS score for at least 4 days) during the screening/baseline period. Eligible subjects underwent PNS surgery and implanted electrode leads and entered the 7-day test period. During the test period, subjects with an average VAS score improvement of ≥30%(VAS score for at least 4 days) will be randomly assigned to the experimental group (on state) or the control group (off state) in a 1:1 ratio for 7 days observation. All subjects were enrolled in the observation period until 28 days after implantation. Safety assessment was performed at a 14-day follow-up after removal of the device.

Sponsors & Collaborators

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-28
Primary Completion
2024-12-01
Completion
2024-12-01

Countries

  • China

Study Locations

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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 NCT05827848 on ClinicalTrials.gov