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Trial Radar IA
Lo studio clinico NCT07089615 per Polipi del colon è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference 330 In aperto

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07089615 è uno studio interventistico per Polipi del colon, attualmente in arruolamento. Avviato il 26 giugno 2025, prevede di arruolare 330 partecipanti. Sotto la guida di Capso Vision, Inc., dovrebbe concludersi entro il 1 gennaio 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 28 luglio 2025.
Sommario breve
Note: This is the same study protocol as NCT04607746 with slight changes to how the videos will be read and a 2nd generation capsule is being studied.

The purpose of this study is to evaluate the safety and effectiveness of CapsoCam® Colon (CV-3) endoscope system for the detection of colonic polyps and to show that AI-based CADe improves the polyp-detection accuracy and efficiency of capsule video readers. It will u...

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Titolo ufficiale

Prospective, Open Label, Pivotal Study of the Accuracy of the CapsoCam® Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference

Patologie
Polipi del colon
Altri ID dello studio
  • CLN-CVI-5794 2nd Generation
Numero NCT
NCT07089615
Data di inizio (effettiva)
2025-06-26
Ultimo aggiornamento pubblicato
2025-07-28
Data di completamento (stimata)
2026-01
Arruolamento (previsto)
330
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Scopo principale
Selezione
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleA new capsule design is being used from that of the first phase of the study.
Capsule swallow
Participant will swallow the investigational device
Esito primario
Misure di esitoDescrizione della misuraArco temporale
Positive Percentage Agreement
• Positive Percent Agreement (PPA) of the study device with computer assisted detection (CADe) for detecting the presence in a subject of the largest polyp detected by optical colonoscopy (OC) if that polyp is ≥ 6 mm, where a match is considered to have occurred if a polyp detected by the device is assessed as having a size within plus or minus 50% of the size of the polyp detected by OC and as having a location within the same or an adjacent colon segment.
From capsule swallow to Colonoscopy - up to 6 weeks
Negative Percentage Agreement
• Negative percent agreement (NPA) of the study device with CADe for not detecting any polyp ≥ 6 mm in a subject for whom OC did not detect any polyp ≥ 6 mm.
From Capsule swallow to colonoscopy - Up to 6 weeks
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
45 Years
Sessi idonei
Tutti
  1. 45-75 years of age
  2. Committed to undergo a colonoscopy.
  3. Choose to participate and must have signed the IRB-approved informed consent document and agreed to release colonoscopy images and results report to Sponsor

  1. Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps
  2. Has contraindication for capsule endoscopy or colonoscopy
  3. Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high-risk genetic syndrome
  4. Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease
  5. History of incomplete colonoscopy
  6. Type I or uncontrolled II Diabetes (Uncontrolled defined as HbA1C>6.4 within the past 3 months and/or with history of constipation or gastroparesis).
  7. Impaired cardiac function assessed as greater than NYHA Class II
  8. History of small- or large-bowel obstructive condition
  9. Known history of swallowing disorder, and/or ischemic bowel disease neuropathies and/or radiation enteritis
  10. Known history of NSAID enteropathy and stricture resulting from taking NSAIDs on a regular basis that, in the opinion of the Investigator, would put the subject at greater risk for capsule endoscope retention
  11. Known allergy to ingredients used in bowel preparation and boosters
  12. Daily and/or regular narcotic use
  13. Decompensated cirrhosis
  14. Prior abdominal radiation therapy
  15. Diagnosis of anorexia or bulimia
  16. History of or suspicion of any of the following: strictures, volvulus or intestinal obstruction, or internal hernias or abdominal surgeries that the Investigator believes should exclude the patient from study participation
  17. Known or suspected megacolon
  18. Scheduled to undergo MRI examination within 7 days after ingestion of the capsule
  19. Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis
  20. Pregnant or nursing or of child-bearing potential and does not agree to practice medically acceptable methods of contraception. Women of child bearing potential (WOCBP) must have a negative urine pregnancy test at screening.
  21. Unable to follow or tolerate fasting, bowel preparation, and other study procedures
  22. Any documented medical or psychological condition or significant concurrent illness which, in the Investigator's opinion, would make it unsafe for the subject to participate in this research study or would affect the validity of the study results
  23. Are currently enrolled in an interventional clinical study or currently enrolled in or within the last 30 days, a pharmaceutical clinical study
  24. Chronic constipation as defined by <3 bowel movements per week, or the use of routine laxatives (other than fiber) to attain regular bowel movements
Capso Vision, Inc. logoCapso Vision, Inc.
Contatti principali dello studio
Contatto: Taylor Williamsen Principle CRA/Study Lead, 815-861-9575, [email protected]
Contatto: Rebecca Petersen Sr. Director of Clinical Affairs, 510-566-8824, [email protected]
11 Centri dello studio in 1 paesi

California

SB Gastro Clinical Research, Chula Vista, California, 91910, United States
Study Coordinator, Contatto, 619-513-3372, [email protected]
Erick Alayo, M.D., Investigatore principale
In arruolamento
Gastro Care Institute, Lancaster, California, 93534, United States
Lead Study Coordinator, Contatto, 661-529-7550, [email protected]
Kumaravel Perumalsamy, M.D., Investigatore principale
In arruolamento
Knowledge Research Center, Orange, California, 92868, United States
Regulatory/Study Coordinator, Contatto, 657-247-0087, [email protected]
Alla Abousaif, M.D., Investigatore principale
In arruolamento

Florida

Advanced Research Institute, St. Petersburg, Florida, 33710, United States
Study Coordinator, Contatto, 727-835-3261, [email protected]
Jatin Bidani, M.D., Investigatore principale
In arruolamento

Illinois

Digestive Health Services, Downers Grove, Illinois, 60515, United States
Site Manager, Contatto, (708) 253-5810, [email protected]
Rockford Yapp, M.D., Investigatore principale
In arruolamento
Gastroenterology and Internal Medicine Specialists, Lake Barrington, Illinois, 60010, United States
Site Manager, Contatto, 708-253-5810, [email protected]
Nicole Gentile, M.D., Investigatore principale
In arruolamento
Northshore Center for Gastroenterology, Libertyville, Illinois, 60048, United States
Site Manager, Contatto, 708-253-5810, [email protected]
Sean Lee, M.D., Investigatore principale
In arruolamento
Suburban Gastroenterology, Naperville, Illinois, 60540, United States
Site Manager, Contatto, 708-253-5810, [email protected]
Thomas Couri, M.D., Investigatore principale
In arruolamento
Southwest Gastroenterology, Oak Lawn, Illinois, 60453, United States
Site Manager, Contatto, 708-253-5810, [email protected]
Kamran Ayub, M.D., Investigatore principale
In arruolamento

New York

Gastroenterology Group of Rochester, Rochester, New York, 14618, United States
Lead Study Coordinator, Contatto, 585-278-1116, [email protected]
Jonathan Wilmot, M.D., Investigatore principale
In arruolamento

Ohio

Great Lakes Gastroenterology Research, Mentor, Ohio, 44060, United States
Lead Clinical Research Coordinator, Contatto, 216-387-4966, [email protected]
Keith Friedenberg, M.D., Investigatore principale
In arruolamento