NCT05074329

Clinical Trial for Idiopathic Hip Pain Using Peripheral Nerve Stimulation

Multi-center, Prospective, Randomized, Controlled, Clinical Trial for Idiopathic Hip Pain Using Peripheral Nerve Stimulation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Uro Medical Corporation · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, multi-center study in which 300 evaluable subjects will be randomized 1:1 to receive Active or Delayed therapy with Moventis PNS. Subjects in the Delayed group will start with therapy at 3-month visit follow up.

Detailed description

This is a prospective, randomized, controlled, multi-center study in which 300 evaluable subjects will receive Moventis PNS. Target subjects will have idiopathic hip pain. Subjects will be randomized into either a delayed or immediate continuation group. Devices will be activated post-op in accordance to the randomization assignment. Subjects randomized to the Active group, programming parameters will be set, and therapy will be delivered for a minimum of 2-hours per day for the duration of the study. Implanted subjects will be educated on the use of the transmitter. Programming changes can be done as needed during this time period to maximize clinical response according to pre-programmed settings. Subjects randomized to the Delayed group will begin 2-hour stimulation/day at the 3-Month visit. The primary endpoint is to demonstrate clinically significant improvements in the pain of patients in the active group compared to the subjects in the delayed group. The primary endpoint is defined as \>50% pain relief at 3-months as measured by the Visual Analog Scale (VAS) without increase in baseline pain medications. Improvement will be assessed in relation to the clinical outcome measures of pain, with a target of \>50% pain relief.

Conditions

• Idiopathic Hip Pain
• Chronic Hip Pain

Interventions

Type	Name	Description
DEVICE	Moventis PNS	Moventis PNS is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin.

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-06-01
• Completion: 2024-06-01
• First posted: 2021-10-12
• Last updated: 2021-10-12

Regulatory

• FDA-regulated device study