MedDataX Logo

BlueWind Medical Reprieve System for the Treatment of PNP

NCT ID: NCT02062398

Last Updated: 2019-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The current study will evaluate the safety and performance of the BlueWind Medical Reprieve System for the treatment of Chronic Painful Peripheral Neuropathy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The BlueWind Reprieve system is a neurostimulator consisting of an Implant and external components.

The system is intended for home care use. The chronic pain treatment is achieved by an electrical stimulation of peripheral nerve fibers. The stimulation is set so that it generates paresthesia in the stimulated area (e.g. foot), reducing the pain sensation and improving the quality of life for the patient.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Neuropathy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

PNP Stimulation Peripheral neurostimulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

The Reprieve system implantation

The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations.

Group Type EXPERIMENTAL

The Reprieve System

Intervention Type DEVICE

BlueWind Medical neurostimulator for the treatment of neuropathic pain

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

The Reprieve System

BlueWind Medical neurostimulator for the treatment of neuropathic pain

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Signed written informed consent.
2. Male or female aged 18 - 80.
3. Patient agrees to attend all follow-up evaluations and is willing to completely and accurately fill out pain questionnaires.
4. Diagnosis of chronic neuropathic pain due to peripheral neuropathy.
5. Documented pain attributed to neuropathy for at least 6 months.
6. Pain intensity with an average daily VAS score of at least 6, demonstrated by 2-3 ratings per day across 7 days.
7. Patient refractory to conservative treatments including pain medication, for at least 6 months.
8. Stable pain medication for at least 4 weeks prior to study enrollment.

Exclusion Criteria

1. Previous participation in another study with any investigational drug or device within the past 90 days.
2. Any active implant (cardiac or other).
3. Any metal implant in the area of BlueWind device implantation site.
4. Current pregnancy or attempting to get pregnant (female patient).
5. Any clinically significant neurologic disorders (except PNP).
6. Any clinically significant or unstable medical or psychiatric condition that would affect the patient's ability to participate in the study.
7. Patients with severe or unstable cardiovascular, pulmonary, gastrointestinal, hematological, hepatic, renal or endocrine diseases.
8. Severe peripheral vascular disease that may cause intermittent claudication or ischemic ulcers.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

BlueWind Medical

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean Pierre Van Buyten, MD

Role: PRINCIPAL_INVESTIGATOR

Sint-Niklaas hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AZ Sint-Jan Brugge - Oostende AV

Bruges, , Belgium

Site Status

AZ Sint-Niklaas Hospital

Sint-Niklaas, , Belgium

Site Status

10 Military Clinical Hospital

Bydgoszcz, , Poland

Site Status

CenterMed Kraków Sp.z o.o.

Krakow, , Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium Poland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CP-02-001

Identifier Type: -

Identifier Source: org_study_id