- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03457909
Detachable String Magnetically Controlled Capsule Endoscopy for Completely Viewing of Esophagus and Stomach
A Novel Detachable String Magnetically Controlled Capsule Endoscopy (DS-MCE) for Viewing Esophagus and Stomach
Studieoversigt
Detaljeret beskrivelse
Esophageal capsule endoscopy(ECE)provides a novel noninvasive approach to visualize the esophagus.The main drawback for the use of ECE is its unreliable transit time which often renders an inadequate visualization of the esophagus.Thus investigators have developed the detachable string magnetically controlled capsule endoscopy(DS-MCE) which can control the movement of the capsule through the string.
This study is a prospective, single-centered, self-controlled pilot study.Outpatients who have esophagus symptoms will take conventional endoscopy examination and DS-MCE successively.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Shanghai
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Shanghai, Shanghai, Kina, 200433
- Changhai 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:
- outpatients who have esophagus symptoms.
Exclusion Criteria:
- known or suspected complex history of gastrointestinal obstruction, stenosis or fistula.
- dysphagia or delayed gastric emptying.
- known or suspected possibility of active bleeding of digestive tract.
- a history of abdominal operation.
- pacemaker implantation and gastrointestinal pacemaker users.
- patients who are allergic to simethicone or pronase.
- pregnant women,mental patients.
- other circumstances that doctors consider inappropriate for the study.
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: DS-MCE
outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination successively.
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During the DS-MCE examination,the capsule is allowed to travel down into gastric cardia,from where the string is slowly pulled to allow the capsule to view the esophagus retrogradely.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Number of Participants With Successful Separation of Capsule and String, and Complete Viewing of Esophagus and Stomach
Tidsramme: up to 2 weeks
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evaluate the feasibility of the novel DS-MCE examination.
The successful separation of the capsule and string was evaluated by the capsule entering the stomach and and the string being pulled out.Complete viewing of esophagus and stomach was evaluated by completing the procedure from the capsule being swallowed, the esophagus observed retrograde, to the string being pulled out after separating from the capsule.This primary outcome indicated how many participatns completed the DS-MCE examination successfully.
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up to 2 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Number of DS-MCE Associated Adverse Events
Tidsramme: up to 2 weeks
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evaluate the safety of DS-MCE.Record any adverse event during the procedure and after the procedure.Patients will be followed up by telephone to inquire about the symptoms of abdominal distention, abdominal pain,vomiting and other discomfort.
Follow up to the end of the capsule expulsion.
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up to 2 weeks
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Duration of Time Capsule is Within the Esophagus
Tidsramme: up to 2 weeks
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time from the capsule swallowed to the capsule entering the gastric cardia to examine the stomach
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up to 2 weeks
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Z-line Visualization
Tidsramme: up to 2 weeks
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Z-line represents the normal esophagogastric junction where the squamous mucosa of the esophagus and columnar mucosa of the stomach meet.We can devide the Z-line into four quadrants under capsule endoscopy.
Observing all the four quadrants is considered to be a complete observation of Z-line.
In this study,the number of participants with at least two quadrants of Z-line visualized was used to evaluate the Z-line visulization.
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up to 2 weeks
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Quality Score of Z-line Images
Tidsramme: up to 2 weeks
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grade (mild, moderate,and severe) of air-bubble and saliva interference on the Z-line view(0, no intraluminal gas bubble; 1, a few gas bubbles, no limitation of interpretation; 2, an increased amount of intraluminal foam/gas bubbles, moderate limitation of visibility; 3, an amount of foam/gas bubbles)
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up to 2 weeks
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Degree of Comfort
Tidsramme: up to 2 weeks
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evaluate patient's degree of comfort throughout the procedure.Patients will be asked to fill in a questionnaire to give scores about degree of comfort throughout the procedure.Overall discomfort was scored on a scale of 0 to 10 (0, no discomfort; 10, the overall discomfort of EGD).
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up to 2 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Zhuan Liao, Changhai Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- DS-MCE-esophagus and stomach
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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Kliniske forsøg med DS-MCE
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Changhai HospitalShanghai Zhongshan Hospital; Ruijin Hospital; Shanghai General Hospital,... og andre samarbejdspartnereRekrutteringEsophageale sygdommeKina
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Changhai HospitalQilu Hospital of Shandong University; First Affiliated Hospital Xi'an Jiaotong... og andre samarbejdspartnereAfsluttetNøjagtighed af magnetisk manøvreret kapselendoskopi til påvisning af GEV hos patienter med cirrhosisLevercirrhose | Portal hypertension | Esophageal Varicer | Gastrisk VarixKina
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Changhai HospitalShanghai Children's Hospital; Xian Children's HospitalIkke rekrutterer endnu
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University of Nove de JulhoUniversity of BergenRekruttering
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Changhai HospitalQilu Hospital of Shandong UniversityAfsluttet
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Oulu University HospitalLoisto Terveys, Oulu; Fysios Kastelli, Oulu; Faskia-Markus, OuluTilmelding efter invitationLændesmerter | Lænderygsmerter, tilbagevendendeFinland
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Changhai HospitalIkke rekrutterer endnu
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Changhai HospitalTrukket tilbage
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Changhai HospitalWuhan Union Hospital, China; Second Military Medical UniversityAfsluttetGastriske symptomer | Indiceret til øvre GI endoskopiKina