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Neuromodulation in Patients With Painful Chronic Pancreatitis

NCT03357029 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-02-17

No results posted yet for this study

Summary

The purpose of this trial is to explore if a novel vagal neuromodulation approach provides analgesic benefit through central mechanisms in patients with chronic pancreatitis

Conditions

  • Painful Chronic Pancreatitis
  • Visceral Pain
  • Neuropathic Pain

Interventions

DEVICE

GammaCore Device

GammaCore will be administered using a handheld device the size of a mobile phone, which consists of a battery powered portable stimulator with a digital control user interface that controls the stimulation amplitude and two steel contact electrodes.

DEVICE

Sham Device

Sham device will be administered using a handheld device the size of a mobile phone, which consists of a battery powered portable stimulator with a digital control user interface that controls the stimulation amplitude and two steel contact electrodes. The sham device is identical in appearance, weight, visual and audible feedback, and user application and control but did not deliver electrical stimulations.

Sponsors & Collaborators

  • ElectroCore INC

    collaborator INDUSTRY

  • Jens Brøndum Frøkjær

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-11
Primary Completion
2019-04-30
Completion
2019-04-30
FDA Device
Yes

Countries

  • Denmark

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 NCT03357029 on ClinicalTrials.gov