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Behavioural Intervention

TEA for Chronic Pancreatitis

N/A

Recruiting

Led By Jorge Machicado, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 1 year (during the recruitment period)

Awards & highlights

Study Summary

This trial looks at the safety and effectiveness of a new noninvasive device-based therapy to treat abdominal pain in patients with chronic pancreatitis.

Who is the study for?

This trial is for adults with chronic pancreatitis who've had abdominal pain at least once in the last month. They must understand English and consent to participate. It's not for pregnant or breastfeeding women, those with a history of pancreatic surgery, recent acute pancreatitis, certain pancreatic complications, long-term opioid use, cancer treatments, other trials participation, electrical device implants, drug abuse issues or specific allergies.Check my eligibility

What is being tested?

The study tests Transcutaneous Electrical Acustimulation (TEA), a non-drug method that might help manage pain without opioids in people with chronic pancreatitis. Participants will use this new therapy to see if it reduces their abdominal pain effectively and safely.See study design

What are the potential side effects?

Since TEA is noninvasive and doesn't involve drugs, side effects may be minimal but could include skin irritation from the adhesive electrodes or discomfort at the site of stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with chronic pancreatitis according to Mayo or Rosemont criteria.

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I have experienced abdominal pain at least once in the past month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 1 year (during the recruitment period)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 1 year (during the recruitment period)

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1 year (during the recruitment period) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Median interquartile range (IQR) of the time that it takes to complete visit number one

Median interquartile range (IQR) of the time that it takes to complete visit number two

Proportion of approached and eligible participants that provide informed consent

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Transcutaneous Electrical Acustimulation (TEA)Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcutaneous Electrical Acustimulation (TEA)

2021

N/A

~30

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,798 Previous Clinical Trials

6,378,128 Total Patients Enrolled

Jorge Machicado, MDPrincipal InvestigatorUniversity of Michigan

1 Previous Clinical Trials

100 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are applicants aged 85 or younger able to participate in the experiment?

"For this trial, participants must be at least 18 years old and not more than 75 years of age."

Answered by AI

What are the entry requirements for participating in this trial?

"This trial is searching for 10 individuals suffering from chronic pancreatitis aged between 18 and 75. To be eligible, they must have experienced abdominal pain in the past month at least once."

Answered by AI

Are volunteers still being recruited for this clinical experiment?

"Clinicaltrials.gov shows that the trial, which was first made available on October 1st 2023 and last updated August 23rd 2023 is no longer actively recruiting patients. Nevertheless, there are still 85 other medical studies seeking participants at this juncture."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Role of Home-based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis

Jorge Machicado, MD, MPH 2023. "Role of Home-based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06015945.

All > Chronic Pancreatitis