Mini-sized MCE for Detection of Small Bowel in Children Under the Age of 10 Years
NCT ID: NCT05522101
Last Updated: 2022-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
158 participants
INTERVENTIONAL
2022-10-20
2023-07-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Mini-sized MCE
AKES-31SW Capsule Endoscopy
Mini-sized MCE
AKES-31SW capsule endoscopy（Mini-sized MCE), its diameter is 9.5mm, length is 24.5mm, weight is 3.0g, shooting frequency is 0.5-6fps, image resolution is 480\*480, working time is not less than 8 hours. Mini-sized MCE is 0.6 times of traditional MCE in volume and weight, which is the smallest capsule in clinical application
Normal sized CE
PillCam Capsule Endoscopy
Normal-sized MCE
Pillcam SB 3 capsule endoscopy（Normal-sized MCE), its diameter is 11.4mm, length is 26.2mm, weight is 3.0g, shooting frequency is 2-6fps, image resolution is 340\*340, working time is not less than 8 hours.
Interventions
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Mini-sized MCE
AKES-31SW capsule endoscopy（Mini-sized MCE), its diameter is 9.5mm, length is 24.5mm, weight is 3.0g, shooting frequency is 0.5-6fps, image resolution is 480\*480, working time is not less than 8 hours. Mini-sized MCE is 0.6 times of traditional MCE in volume and weight, which is the smallest capsule in clinical application
Normal-sized MCE
Pillcam SB 3 capsule endoscopy（Normal-sized MCE), its diameter is 11.4mm, length is 26.2mm, weight is 3.0g, shooting frequency is 2-6fps, image resolution is 340\*340, working time is not less than 8 hours.
Eligibility Criteria
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Inclusion Criteria
* 2 years ≤ age \< 10 years;
* Pediatric patients with suspected small bowel disease who are scheduled for small bowel capsule endoscopy
Exclusion Criteria
* Dysphagia or gastric emptying dysfunction;
* Severe asthma, dysphagia or gastroparesis and other emptying disorders;
* Known or suspected possibility of major bleeding from active digestive tract;
* The presence of a pacemaker in the body, except where the pacemaker is a new MRI-compatible product;
* Implanted cochlear implants, magnetic metal drug infusion pumps, nerve stimulators and other electronic devices, as well as magnetic metal foreign bodies;
* Those who plan to undergo magnetic resonance imaging (MRI) examination before capsule endoscopy discharge;
* Previous history of abdominal surgery affecting the normal structure of the digestive tract;
* Patients with mental illness;
* Allergic to macromolecular materials such as dimethyl silicone oil;
* Refuse to use electronic gastroscopy to deliver the capsule to the duodenum if the capsule cannot be swallowed by itself;
* Contraindications of intravenous anesthesia;
* Patients who have participated in or are participating in other clinical trials within three months;
* Any other factors considered by the investigator to be inappropriate for enrollment or to affect the participant's participation in the study.
2 Years
9 Years
ALL
Yes
Sponsors
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Shanghai Children's Hospital
OTHER
Xian Children's Hospital
OTHER_GOV
Changhai Hospital
OTHER
Responsible Party
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Zhuan Liao
Professor
Principal Investigators
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Zhuan Liao
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital
Locations
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Qilu Children's Hospital
Jinan, , China
Shanghai Changhai Hospital
Shanghai, , China
Shanghai Children's Hospital
Shanghai, , China
Xi'an Children's Hospital
Xi'an, , China
Countries
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Central Contacts
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Facility Contacts
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Junjie Xu
Role: primary
Haifeng Liu
Role: primary
Ying Fang
Role: primary
References
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Swaminath A, Legnani P, Kornbluth A. Video capsule endoscopy in inflammatory bowel disease: past, present, and future redux. Inflamm Bowel Dis. 2010 Jul;16(7):1254-62. doi: 10.1002/ibd.21220.
Arguelles-Arias F, Donat E, Fernandez-Urien I, Alberca F, Arguelles-Martin F, Martinez MJ, Molina M, Varea V, Herrerias-Gutierrez JM, Ribes-Koninckx C. Guideline for wireless capsule endoscopy in children and adolescents: A consensus document by the SEGHNP (Spanish Society for Pediatric Gastroenterology, Hepatology, and Nutrition) and the SEPD (Spanish Society for Digestive Diseases). Rev Esp Enferm Dig. 2015 Dec;107(12):714-31. doi: 10.17235/reed.2015.3921/2015.
Urs AN, Martinelli M, Rao P, Thomson MA. Diagnostic and therapeutic utility of double-balloon enteroscopy in children. J Pediatr Gastroenterol Nutr. 2014 Feb;58(2):204-12. doi: 10.1097/MPG.0000000000000192.
Gu Z, Wang Y, Lin K, Wang X, Cheng W, Wang L, Zhang T, Liu H. Magnetically Controlled Capsule Endoscopy in Children: A Single-center, Retrospective Cohort Study. J Pediatr Gastroenterol Nutr. 2019 Jul;69(1):13-17. doi: 10.1097/MPG.0000000000002292.
Cardey J, Le Gall C, Michaud L, Dabadie A, Talbotec C, Bellaiche M, Lamireau T, Mas E, Bridoux-Henno L, Viala J, Restier-Miron L, Lachaux A. Screening of esophageal varices in children using esophageal capsule endoscopy: a multicenter prospective study. Endoscopy. 2019 Jan;51(1):10-17. doi: 10.1055/a-0647-1709. Epub 2018 Sep 5.
Pai AK, Jonas MM, Fox VL. Esophageal Capsule Endoscopy in Children and Young Adults With Portal Hypertension. J Pediatr Gastroenterol Nutr. 2019 Dec;69(6):641-647. doi: 10.1097/MPG.0000000000002455.
Oliva S, Di Nardo G, Hassan C, Spada C, Aloi M, Ferrari F, Redler A, Costamagna G, Cucchiara S. Second-generation colon capsule endoscopy vs. colonoscopy in pediatric ulcerative colitis: a pilot study. Endoscopy. 2014 Jun;46(6):485-92. doi: 10.1055/s-0034-1365413. Epub 2014 Apr 28.
Xie M, Qian Y, Cheng S, Wang L, Shen R. Magnetically Guided Capsule Endoscopy in Pediatric Patients with Abdominal Pain. Gastroenterol Res Pract. 2019 May 8;2019:7172930. doi: 10.1155/2019/7172930. eCollection 2019.
Fritscher-Ravens A, Scherbakov P, Bufler P, Torroni F, Ruuska T, Nuutinen H, Thomson M, Tabbers M, Milla P. The feasibility of wireless capsule endoscopy in detecting small intestinal pathology in children under the age of 8 years: a multicentre European study. Gut. 2009 Nov;58(11):1467-72. doi: 10.1136/gut.2009.177774. Epub 2009 Jul 21.
Radhakrishnan C, Sefidani Forough A, Cichero JAY, Smyth HE, Raidhan A, Nissen LM, Steadman KJ. A Difficult Pill to Swallow: An Investigation of the Factors Associated with Medication Swallowing Difficulties. Patient Prefer Adherence. 2021 Jan 11;15:29-40. doi: 10.2147/PPA.S277238. eCollection 2021.
Ohmiya N, Oka S, Nakayama Y, Iwama I, Nakamura M, Shimizu H, Sumioka A, Abe N, Kudo T, Osawa S, Honma H, Okuhira T, Mtsufuji S, Imaeda H, Ota K, Matsuoka R, Hotta N, Inoue M, Nakaji K, Takamaru H, Ozeki K, Kobayashi T, Hosoe N, Tajiri H, Tanaka S. Safety and efficacy of the endoscopic delivery of capsule endoscopes in adult and pediatric patients: Multicenter Japanese study (AdvanCE-J study). Dig Endosc. 2022 Mar;34(3):543-552. doi: 10.1111/den.14104. Epub 2021 Sep 10.
Burgess CJ, McIntyre EC, Withers GD, Ee LC. Comparing swallowing of capsule to endoscopic placement of capsule endoscopy in children. JGH Open. 2017 Sep 18;1(1):11-14. doi: 10.1002/jgh3.12001. eCollection 2017 Sep.
Dan T, Dandan S, Enqiang L. Aspiration of a Magnetically Controlled Capsule Endoscopy. Gastroenterology. 2023 May;164(6):e30-e31. doi: 10.1053/j.gastro.2019.04.006. Epub 2019 Apr 11. No abstract available.
Melson J, Trikudanathan G, Abu Dayyeh BK, Bhutani MS, Chandrasekhara V, Jirapinyo P, Krishnan K, Kumta NA, Pannala R, Parsi MA, Sethi A, Trindade AJ, Watson RR, Maple JT, Lichtenstein DR. Video capsule endoscopy. Gastrointest Endosc. 2021 Apr;93(4):784-796. doi: 10.1016/j.gie.2020.12.001. Epub 2021 Feb 26. No abstract available.
Jiang B, Qian YY, Pan J, Jiang X, Wang YC, Zhu JH, Zou WB, Zhou W, Li ZS, Liao Z. Second-generation magnetically controlled capsule gastroscopy with improved image resolution and frame rate: a randomized controlled clinical trial (with video). Gastrointest Endosc. 2020 Jun;91(6):1379-1387. doi: 10.1016/j.gie.2020.01.027. Epub 2020 Jan 22.
Eliakim R. Where do I see minimally invasive endoscopy in 2020: clock is ticking. Ann Transl Med. 2017 May;5(9):202. doi: 10.21037/atm.2017.04.17.
Meltzer EO, Welch MJ, Ostrom NK. Pill swallowing ability and training in children 6 to 11 years of age. Clin Pediatr (Phila). 2006 Oct;45(8):725-33. doi: 10.1177/0009922806292786.
Other Identifiers
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Mini-sized MCE
Identifier Type: -
Identifier Source: org_study_id
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