- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Shanghai
-
Shanghai, Shanghai, Chine, 200433
- Changhai Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: DS-MCE
outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination successively.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Number of Participants With Successful Separation of Capsule and String, and Complete Viewing of Esophagus and Stomach
Délai: up to 2 weeks
|
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.
|
up to 2 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Number of DS-MCE Associated Adverse Events
Délai: up to 2 weeks
|
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.
|
up to 2 weeks
|
Duration of Time Capsule is Within the Esophagus
Délai: up to 2 weeks
|
time from the capsule swallowed to the capsule entering the gastric cardia to examine the stomach
|
up to 2 weeks
|
Z-line Visualization
Délai: up to 2 weeks
|
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.
|
up to 2 weeks
|
Quality Score of Z-line Images
Délai: up to 2 weeks
|
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)
|
up to 2 weeks
|
Degree of Comfort
Délai: up to 2 weeks
|
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).
|
up to 2 weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Zhuan Liao, Changhai Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- DS-MCE-esophagus and stomach
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur DS-MCE
-
Zhuan LiaoInconnueEndoscopie capsulaireChine
-
Changhai HospitalShanghai Zhongshan Hospital; Ruijin Hospital; Shanghai General Hospital, Shanghai... et autres collaborateursRecrutement
-
Changhai HospitalQilu Hospital of Shandong University; First Affiliated Hospital Xi'an Jiaotong... et autres collaborateursComplétéLa cirrhose du foie | Hypertension portale | Varices oesophagiennes | Varices gastriquesChine
-
University of Nove de JulhoUniversity of BergenRecrutement
-
Oulu University HospitalLoisto Terveys, Oulu; Fysios Kastelli, Oulu; Faskia-Markus, OuluInscription sur invitationLombalgie | Lombalgie, récurrenteFinlande
-
Changhai HospitalQilu Hospital of Shandong UniversityComplétéEndoscopie capsulaireChine
-
Changhai HospitalShanghai Children's Hospital; Xian Children's HospitalPas encore de recrutementMaladie de l'intestin grêleChine
-
Changhai HospitalPas encore de recrutement
-
Changhai HospitalWuhan Union Hospital, China; Second Military Medical UniversityComplétéSymptômes gastriques | Indiqué pour l'endoscopie gastro-intestinale supérieureChine