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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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 8 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a small, non-invasive device called IB-Stim that sends mild electrical signals to reduce abdominal pain in children with Cystic Fibrosis. The device works by stimulating a nerve that helps control pain, aiming to improve their quality of life.

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

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
CFQ-R and PedsQL Gastrointestinal Scale Score in Response to IB-Stim Treatment- Baseline and Week 8 Reported
IBS Severity Scoring System-Change Between Baseline and Week 8 is Reported.
Reduction in Stool Calprotectin Inflammatory Markers in Response to IB-Stim-change Between Two Time Point is Reported.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
41,022 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
3 Patients Enrolled for Cystic Fibrosis
Washington University School of MedicineOTHER
1,991 Previous Clinical Trials
2,295,883 Total Patients Enrolled
7 Trials studying Cystic Fibrosis
851 Patients Enrolled for Cystic Fibrosis
~0 spots leftby Nov 2025
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