A Prospective Trial of a Variable Compression System for Moderate to Severe Irritable Bowel Syndrome
A legfontosabb adatok
- Hol
- Bolingbrook, Kissimmee és Southhaven (Egyesült Államok)Mind a 3 helyszín megnézése
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 60 év között vagy?
Forrás: NCT07540312: ki vehet részt
Helyszínek itt: Egyesült Államok
- UChicago Medicine AdventHealth Medical Group Gastroenterology at BolingbrookBolingbrook, Egyesült ÁllamokContact: Hadi Saddiqui, DO, MPH (principal investigator)Résztvevőt keres
- Central Florida Gastro ResearchKissimmee, Egyesült ÁllamokContact: Muhammad Mohiuddin, MD (principal investigator)Résztvevőt keres
- Delta Gastroenterology PCSouthhaven, Egyesült ÁllamokContact: Ulric Duncan, MD (principal investigator)Résztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- PGP Health
- Azonosító
- NCT07540312
- A regiszteradat frissítve
- 2026. április 29.
- Eredeti leírás
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 teljes eredeti leírásKevesebb
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.
Bevonási feltételek: 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).
Kizáró feltételek: Allergy to the investigational device or any components or clinically significant allergies (excluding mild seasonal allergies), in the opinion of the investigator; Hospital admission or major surgery within 30 days prior to screening; Participation in any other investigational drug trial within 30 days prior to screening; 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; 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; Pregnant, or positive urine pregnancy test.