- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01360801
High Definition White Light Endoscopy and Narrow Band Imaging for the Assessment of Barrett's Disease After Endoscopic Therapy
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Florida
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Jacksonville, Florida, Förenta staterna, 32224
- Mayo Clinic
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Accuracy of Agreement Between Imaging and Histology
Tidsram: 9 months
|
The accuracy of agreement between endoscopic imaging diagnosis compared with biopsy histology diagnosis.
|
9 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Presence of Residual Disease
Tidsram: 9 months
|
Presence of any residual Barrett's disease at follow-up endoscopy after ablation / resection treatment.
|
9 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Herbert C. Wolfsen,, M.D., Mayo Clinic
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 10-003234
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Kliniska prövningar på Barretts matstrupe
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Erbe Elektromedizin GmbHNAMSA; Kansas City Veteran Affairs Medical Center; Erbe USA IncorporatedAvslutadBarretts matstrupe | Höggradig dysplasi i Barrett Esophagus | Låggradig dysplasi i Barrett EsophagusFörenta staterna
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University Medical Center GroningenAvslutadMatstrupscancer | Barrett Esophagus | Dysplasi i Barrett EsophagusNederländerna
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International Agency for Research on CancerUniversity of Cambridge; Kilimanjaro Clinical Research InstituteAvslutad
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Nantes University HospitalRekryteringBarrett EsophagusFrankrike
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Columbia UniversityNational Cancer Institute (NCI); University of MichiganRekrytering
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Professor Michael BourkeRekryteringBarretts matstrupeAustralien
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Dallas VA Medical CenterAvslutad
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Massachusetts General HospitalNational Cancer Institute (NCI)AvslutadBarretts matstrupeFörenta staterna
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Massachusetts General HospitalNational Cancer Institute (NCI); National Institutes of Health (NIH)Aktiv, inte rekryterandeBarretts matstrupeFörenta staterna
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University of MichiganAvslutadBarrett EsophagusFörenta staterna