IBS (Irritable Bowel Syndrome)NCT07540312
A Prospective Trial of a Variable Compression System for Moderate to Severe Irritable Bowel Syndrome
A study testing Variable Compression System in people with IBS (Irritable Bowel Syndrome), run by PGP Health at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- IBS (Irritable Bowel Syndrome)
- What is being tested?
- Variable Compression System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 May 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
UChicago Medicine AdventHealth Medical Group Gastroenterology at Bolingbrook
Bolingbrook, Illinois, 60440
Hadi Saddiqui, DO, MPH
- Recruiting
Central Florida Gastro Research
Kissimmee, Florida, 34741
Muhammad Mohiuddin, MD
- Recruiting
Delta Gastroenterology PC
Southhaven, Mississippi, 38671
Ulric Duncan, MD
About this study
Official title: A Prospective Interventional Trial With a Non-invasive Variable Compression System (VCS) to Determine the Efficacy in Patients With Moderate to Severe Irritable Bowel Syndrome (IBS)
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.
- Conditions
- IBS (Irritable Bowel Syndrome)
- Being tested
- Variable Compression System
- Keywords
- Variable Compression System, VCS, Irritable Bowel Syndrome, IBS
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Variable Compression SystemDevice
The VCS is a wearable device that provides compression of the lower abdomen, torso support, and covers the torso in Far Infrared Radiation (FIR).
| Study group | Role | What they receive |
|---|---|---|
| Pilot VCS Cohort | Experimental | Wear VCS device for 6+ hours per day Receives: Device: Variable Compression System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intolerable treatment-related adverse events (AEs)
Measured: 21 days
Incidence, severity, and causal relationship of treatment-emergent AEs (TEAEs)
Measured: 21 days
Secondary outcomes (1)
Change in IBS-related symptoms
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start21 May 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS (Irritable Bowel Syndrome)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PGP Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540312
- Sponsor's protocol ID
- VCS-IBS-11072024
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Interventional Trial With a Non-invasive Variable Compression System (VCS) to Determine the Efficacy in Patients With Moderate to Severe Irritable Bowel Syndrome (IBS)
- ClinicalTrials.gov ID
- NCT07540312
- Acronym / sponsor ID
- VCS-IBS-11072024
- Conditions
- IBS (Irritable Bowel Syndrome)
- Keywords
- Variable Compression System, VCS, Irritable Bowel Syndrome, IBS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- PGP HealthIndustry (pharma, biotech, devices)
- Study start
- 21 May 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot VCS Cohort | Experimental | Device: Variable Compression SystemWear VCS device for 6+ hours per day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Variable Compression SystemThe VCS is a wearable device that provides compression of the lower abdomen, torso support, and covers the torso in Far Infrared Radiation (FIR). | Device | Pilot VCS Cohort |
Primary outcome
Incidence of intolerable treatment-related adverse events (AEs)
Time frame: 21 days
Incidence, severity, and causal relationship of treatment-emergent AEs (TEAEs)
Time frame: 21 days
1 secondary outcome
Change in IBS-related symptoms
Time frame: 21 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Variable Compression System in people with IBS (Irritable Bowel Syndrome), run by PGP Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agim Beshiri, MD (+12623448468, agim.beshiri@cmoproconsult.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intolerable treatment-related adverse events (AEs) (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.