Brug af Spectrally Encoded Confocal Microscopy (SECM) til at afbilde spiserøret
Pilotundersøgelse til at afbilde spiserøret ved hjælp af spektralt kodet konfokal mikroskopi (SECM)
The goal of this study is to test the feasibility and the tolerability of a tethered spectrally encoded confocal microscopy (SECM) capsule and to use it to image the esophagus.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
96 participants including healthy volunteers, patients with a suspicion of having Eosinophilic Esophagitis (EoE) and patients with a current or prior clinical diagnosis of EoE will be recruited and asked to swallow the SECM capsule while being awake and unsedated. The capsule is attached to a tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using natural propulsive force called peristalsis.
As the capsule progresses, multiple 2-dimensional cross-sectional images of the esophagus are acquired. Images are analyzed at a later stage.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General hospital
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Participant must be a healthy volunteer
- OR participant must have a suspicion of EoE
- OR participant must have a prior clinical suspicion of EoE
- Participant must be older than 14 years of age
- Participant must be able to give informed consent
Exclusion Criteria:
- Participants with the inability to swallow pills and capsules.
- Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
- Participants with prior endoscopic ablation or resection treatment of Barrett's Esophagus (BE)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Imaging
Participant will swallow the SECM capsule and Imaging will be performed using the SECM Imaging system. |
Imaging of the esophagus using the SECM capsule and system |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
SECM Imaging quality. Assessed qualitative values like resolution, tissue architecture, background scatter etc.
Tidsramme: A single 20 minute visit (5-7 minute imaging).
|
An investigator will qualitatively assess the the Feasibility of SECM Capsule and Imaging in EoE participant versus Healthy Controls. He will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed. The images obtained by the SECM Capsule will be compared to the images obtained by clinical endoscopy if available. |
A single 20 minute visit (5-7 minute imaging).
|
|
Tolerability of SECM Capsule Imaging Procedure in Healthy and EoE Participant, measured by feedback scores.
Tidsramme: Questionnaire adminstered directly after the imaging portion has been completed.
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After participating in the study, the participants will be asked for feedback about tolerability of the procedure using a questionnaire. This entails questions about discomfort levels and the participants ability to tolerate the tether and capsule during the whole and parts of the procedures. using a 0 -10 scale, participants will score how comfortable the procedure was during each stage. 10 being the most discomfort and 0 being the least discomfort. |
Questionnaire adminstered directly after the imaging portion has been completed.
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Guillermo Tearney, MD., PhD, Massachusetts General Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2013-P000863
- 5R01DK091923-03 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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