New device offers Drug-Free hope for pancreatitis pain
NCT ID NCT06015945
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This small pilot study tested a safe, non-invasive device that uses mild electrical pulses on the skin to help reduce belly pain in people with chronic pancreatitis. The goal was to see if patients would use the device at home and if it could be a drug-free option for pain. The study enrolled 12 adults with chronic pancreatitis and tracked how many completed the treatment and surveys.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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12 people
The number who actually took part.
- Started
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Oct 2023
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosis of chronic pancreatitis (CP), based on a score greater or equal to 4 using a previously validated Mayo scoring system that uses morphologic and functional criteria, or endosonographic features suggestive or consistent with CP based on Rosemont criteria. * Abdominal pain present at least once within the last month * Willing and able to provide written informed consent Exclusion Criteria: * Pregnancy or breastfeeding mother * Imprisoned individuals * Non-English speaking patients * Scheduled for or with a history of pancreatic surgery (e.g. Total Pancreatectomy with Islet Auto Transplantation (TPIAT), Puestow, Frey, Whipple, other) * Currently undergoing or about to start endoscopic therapy with Endoscopic retrograde cholangiopancreatography (ERCP) or Endoscopic ultrasound (EUS) * Recent history of acute pancreatitis as defined by the Revised Atlanta Classification within a month prior to enrollment * Radiologic and clinical findings consistent with symptomatic pseudocyst, wall-off necrosis, infected pancreatic necrosis, or biliary obstruction within the last 6 months * Self-reported daily use of opioids for \> 12 months for weak opioids (codeine, tramadol and hydrocodone) or \> 6 months for strong opioids (other opioids) in the last two years. -Self-reported ongoing illicit drug use or abuse- * Suspected or diagnosed pancreatic cancer * Receiving chemotherapy for cancer * Known allergy to adhesive electrocardiogram (ECG) electrodes * Patients with bilateral below the knee amputation * Patients with lower extremity paralysis * Patient is participating in another clinical trial * Patients with an implantable electrical stimulation device.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Michigan
Ann Arbor, Michigan, 48109, United States
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Other studies related to the condition(s) this trial covers.
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