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Neurostimulation Device

Patient open label intervention arm for Cystic Fibrosis

N/A
Waitlist Available
Research Sponsored by St. Louis University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Minimum of 2 days of abdominal pain/week for a duration of two months or greater prior to starting the study
Abdominal pain is not explained by any major organic etiology and comprehensive work up failed to identify any single cause for patients' symptoms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-4 weeks and 4-8 weeks
Awards & highlights

Study Summary

This trial will test a new device to help manage chronic abdominal pain in children with Cystic Fibrosis.

Eligible Conditions
  • Cystic Fibrosis
  • Irritable Bowel Syndrome
  • Chronic Pain

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been experiencing stomach pain for at least 2 days each week for the past 2 months or more.
Select...
You have ongoing abdominal pain that doctors couldn't find a specific reason for, even after doing multiple tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-4 weeks and 4-8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-4 weeks and 4-8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Hypesthesia
To determine whether PENFS therapy improves abdominal pain and IBS-symptom severity in CF.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patient open label intervention armExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

St. Louis UniversityLead Sponsor
194 Previous Clinical Trials
43,654 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
3 Patients Enrolled for Cystic Fibrosis
Washington University School of MedicineOTHER
1,933 Previous Clinical Trials
2,299,724 Total Patients Enrolled
5 Trials studying Cystic Fibrosis
251 Patients Enrolled for Cystic Fibrosis

Frequently Asked Questions

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

Is it possible for me to become a participant in this clinical investigation?

"This clinical trial aims to recruit 20 minors between 11 and 18 years old who are suffering from chronic pain. Applicants should be native English speakers, familiar with the protocol of consenting, come from a variety of racial/ethnic backgrounds and both genders, have had at least 2 days per week abdominal discomfort for two months prior to participating in the study, obtain an average weekly abdominal score rating higher than 3 on a 0-10 point scale before enrollment into the experiment (and not due to any underlying organic cause) and continue until their eighteenth birthday if they turn eighteen during participation."

Answered by AI

Are there any vacancies left in this clinical experiment?

"Clinicaltrials.gov data indicates that this research project is no longer recruiting new subjects, having initially been posted on November 1st 2022 and its last update occurring on October 19th 2022. However, there are presently 925 other trials actively seeking enrollees."

Answered by AI

Does this research protocol accept participants aged sixty and above?

"This study requires that participants be between 11 and 18 years old, with 133 clinical trials listed for minors and 823 for adults above 65."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Neuromodulation for Children With Cystic Fibrosis Experiencing Chronic Abdominal Pain
Dhiren Patel, MD 2023. "Neuromodulation for Children With Cystic Fibrosis Experiencing Chronic Abdominal Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05515250.
~0 spots leftby Apr 2025
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