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The Mamma HiToP Study

NCT06132776 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-04-26

No results posted yet for this study

Summary

The HiToP ® 191 PNP an certified device licensed for the treatment of neuropathia.

The home-based treatment is to be performed only in accordance with the approved Investigational Plan (CIP) on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.

The study is multicenter, randomized, double-blind, and placebo-controlled.

Primary Objective: Comparison of the change of paresthesias from baseline until end of therapy between the two patient groups, assessed by questionnaires

Secondary Objectives: Further symptoms of neuropathy as well as on health-related quality of life.

Conditions

  • Chemotherapy-induced Peripheral Neuropathy

Interventions

DEVICE

HiToP 191 PNP

High tone therapy

DEVICE

Placebo device

Placebo therapy

Sponsors & Collaborators

  • Vienna Hospital Association

    lead OTHER_GOV

Principal Investigators

  • Tatjana Paternostro-Sluga, MD · Vienna Healthcare Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-03
Primary Completion
2024-11-02
Completion
2024-12-31

Countries

  • Austria

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 NCT06132776 on ClinicalTrials.gov