NCT07540312 A Prospective Trial of a Variable Compression System for Moderate to Severe Irritable Bowel Syndrome
| NCT ID | NCT07540312 |
| Status | Recruiting |
| Phase | — |
| Sponsor | PGP Health |
| Condition | IBS (Irritable Bowel Syndrome) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-05-21 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-05-21 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This prospective, interventional trial is intended to determine the safety and effectiveness of the Variable Compression System (VCS) device for Irritable Bowel Syndrome (IBS). This pilot study will enroll 20 subjects who will be required to wear the VCS device for a minimum of 6 hours a day and follow up at 21 days, 8 weeks, and 6 months post-device administration.
Eligibility Criteria
Inclusion Criteria: * Written informed consent to participate in the trial as prescribed. * Subjects with a weight of ≥50 kg and a body mass index between 18 and 40 kg/m2. * Diagnosed with IBS(C)-constipation, IBS(D)-diarrhea, or IBS(M)-mixed patients' diagnosis according to Rome Criteria (moderate to severe). Exclusion Criteria: * Allergy to the investigational device or any components or clinically significant allergies (excluding mild seasonal allergies), in the opinion of the investigator. * Clinically relevant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or psychiatric disorders making implementation of the protocol or interpretation of the trial results difficult, or that would put the participant at risk by participating in the trial in the opinion of the Investigator. * Hospital admission or major surgery within 30 days prior to screening. * Pregnant, or positive urine pregnancy test. * Participation in any other investigational drug trial within 30 days prior to screening. * Participant with substance use disorder (SUD) and/or alcohol use disorder (AUD). * Participant who has other conditions that may affect compliance in the opinion of the investigator, or who are unable to participate in the trial on his/her own. * Participant with end stage organ disease.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07540312 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying IBS (Irritable Bowel Syndrome). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07540312 currently recruiting?
Yes, NCT07540312 is actively recruiting participants. Contact the research team at agim.beshiri@cmoproconsult.com for enrollment information.
Where is the NCT07540312 trial being conducted?
This trial is being conducted at Kissimmee, United States, Bolingbrook, United States, Southhaven, United States.
Who is sponsoring the NCT07540312 clinical trial?
NCT07540312 is sponsored by PGP Health. The trial plans to enroll 20 participants.