- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01360801
High Definition White Light Endoscopy and Narrow Band Imaging for the Assessment of Barrett's Disease After Endoscopic Therapy
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Florida
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Jacksonville, Florida, Forenede Stater, 32224
- Mayo Clinic
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Age 18 years and older
- Patients with Barrett's esophagus (BE) dysplasia as the original indication for treatment
- Undergoing any type of endoscopic BE resection or ablation treatment including RFA, cryotherapy, photodynamic therapy, or EMR, or combinations of these.
- <1cm of circumferential, peninsular, or island-type BE on prior endoscopy or ablation
- Ability to provide written, informed consent
Deferral Criteria: This category is for patients in two specific situations, 1) Erosive esophagitis, and, 2) presence of a nodule suspicious for the presence of neoplasia.
- Erosive esophagitis: patients found to have erosive esophagitis, will be deferred for up to 3 months from their Index study procedure, to permit more aggressive medical therapy to heal the erosive esophagitis. After healing, the Index study procedure will be performed up to 3 months later, and the follow-up endoscopy (and study closure) performed 3 to 6 months after that (total of no more than 9 months).
- Presence of nodule suspicious for neoplasia: for patients found to have such nodular lesions, the Index study procedure will be deferred for 3 months, while Endoscopic Mucosal Resection is performed and subsequently heals.
Note: Only one deferral per patient is permitted, and this one deferral is allowed only for these specific criteria. The end of the study will be defined by the time of follow-up of the last patient who was not deferred; any deferred patients who have not completed follow-up procedures by that time, may miss their follow-up visit as part of the study. (This is to prevent the possibility of delaying the close of the study due to deferral of a procedure late in the study.)
Exclusion Criteria:
- Current participation in another clinical study
- Complete eradication of BE documented by biopsies in 3 or more previous endoscopic procedures performed after resection/ablation
- Inability to obtain biopsies due to anticoagulation, varices, etc.
- Pregnancy
- Worse than Grade C erosive esophagitis
- Less than 3 weeks from previous endoscopy with biopsy or 6 weeks from previous endoscopic therapy (ablation or resection).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Accuracy of Agreement Between Imaging and Histology
Tidsramme: 9 months
|
The accuracy of agreement between endoscopic imaging diagnosis compared with biopsy histology diagnosis.
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9 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Presence of Residual Disease
Tidsramme: 9 months
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Presence of any residual Barrett's disease at follow-up endoscopy after ablation / resection treatment.
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9 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Herbert C. Wolfsen,, M.D., Mayo Clinic
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 10-003234
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Barretts spiserør
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Digma Medical Ltd.Ikke rekrutterer endnu
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-
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-
University Medical Center GroningenIkke rekrutterer endnuBarrett Esophagus Adenocarcinom | Barrett's Esophagus With or Without DysplasiaHolland
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Tomasz RomańczykAfsluttetHeterotopisk maveslimhinde i den proksimale esophagusPolen
-
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Johns Hopkins UniversityAmerican Society for Gastrointestinal Endoscopy; Pentax Medical CorporationAfsluttetBarretts esophagus, esophageal intraepithelial neoplasiForenede Stater, Tyskland
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University Hospital, AntwerpKarolinska University Hospital; Karolinska Institutet; Rigshospitalet, Denmark og andre samarbejdspartnereIkke rekrutterer endnuBarrett Esophagus | Gastroenterologi | Barrett Esophagus Adenocarcinom | Adenocarcinom - GEJ | Gastroenterologisk kræftDanmark, Belgien, Sverige, Irland, Italien, Frankrig, Tyskland
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Coordinación de Investigación en Salud, MexicoSuspenderetIntestinal Metaplasi | Dysplasi | Barretts esophagus med lavgradig dysplasiMexico