BridgeMD
New treatment option for IBS (Irritable Bowel Syndrome)
Official title A Prospective Trial of a Variable Compression System for Moderate to Severe Irritable Bowel Syndrome
ClinicalTrials.gov ID: NCT07540312
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Written informed consent to participate in the trial as prescribed.
- people 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).
You likely can't join if
- Allergy to the investigational device or any components or clinically significant allergies (excluding mild seasonal allergies), in the opinion of...
- Clinically relevant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic...
- 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).
See the full eligibility criteria
- Written informed consent to participate in the trial as prescribed.
- people 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).
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Kissimmee, Florida, United States
- Bolingbrook, Illinois, United States
- Southhaven, Mississippi, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kissimmee, Florida, United States; Bolingbrook, Illinois, United States; Southhaven, Mississippi, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.