Small Bowel DiseaseNCT05522101
Mini-sized MCE for Detection of Small Bowel in Children Under the Age of 10 Years
A study testing Mini-sized MCE and Normal-sized MCE in people with Small Bowel Disease, run by Changhai Hospital at 4 sites in China.
Trial summary
In this prospective randomized controlled trial, pediatric volunteers were enrolled and randomly underwent mini-sized MCE and normal-sized CE to compare the success rate of self-swallowing between mini-sized MCE and normal-sized CE during gastrointestinal examination. Read more about this study
- Who is it for?
- Ages 2 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Small Bowel Disease
- What is being tested?
- Mini-sized MCE and Normal-sized MCE
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 4 sitesChina
- Study dates
- 20 Oct 2022to 20 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients and their legal guardians agreed to participate in the study and signed informed consent;
- 2 years ≤ age < 10 years;
- Pediatric patients with suspected small bowel disease who are scheduled for small bowel capsule endoscopy
Who cannot join
- Intestinal obstruction, stenosis, or fistula is known or suspected;
- 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;
Show all 14Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Qilu Children's Hospital
Jinan
Junjie Xu
Shanghai Changhai Hospital
Shanghai
Shanghai Children's Hospital
Shanghai
Haifeng Liu
Xi'an Children's Hospital
Xi'an
Ying Fang
About this study
Official title: Mini-sized Magnetically Controlled Capsule Endoscopy vs. Normal-sized CE for Detection of Small Bowel in Children Under the Age of 10 Years：A Prospective，Multi-center，Randomized Controlled Trial
In this prospective randomized controlled trial, pediatric volunteers were enrolled and randomly underwent mini-sized MCE and normal-sized CE to compare the success rate of self-swallowing between mini-sized MCE and normal-sized CE during gastrointestinal examination.
Read the detailed description
Magnetic controlled capsule endoscopy (MCE) is comparable to traditional gastroscopy (EGD) in the diagnosis of gastric diseases, and has been widely used in clinical practice. However, there are still some limitations in the application of MCE in digestive tract examination. Due to the large size of capsules at present, some patients have difficulty swallowing capsules during capsule swallowing, which leads to the failure of examination, and the proportion is higher in children patients. Therefore, in order to further improve the patient's comfort in swallowing capsules, our team developed a small MCE with a smaller size combined with innovation, which is 0.6 times of the conventional MCE in terms of volume and weight. This study aims to clarify the application efficacy of mini-MCE in gastrointestinal examination of adults and children through a multicenter clinical study comparing conventional capsule endoscopy with mini-magnetic-controlled capsule endoscopy. In order to ensure the efficacy of the capsule in the examination of digestive tract mucosa, and improve the ease of swallowing in children.
- Conditions
- Small Bowel Disease
- Being tested
- Mini-sized MCE, Normal-sized MCE
- Keywords
- Children, Small Bowel Disease, Capsule Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-sized MCEDevice
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 MCEDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Mini-sized MCE | Experimental | AKES-31SW Capsule Endoscopy Receives: Device: Mini-sized MCE |
| Normal sized CE | Placebo comparator | PillCam Capsule Endoscopy Receives: Device: Normal-sized MCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of self-swallowing with Mini-sized MCE
Self-swallowing was defined as the subjects swallowing capsules for examination by themselves, and no endoscope or other instruments were needed to place capsules during the entire examination process
Measured: 2 weeks
Secondary outcomes (20)
Completion rate of capsule endoscopy gastric examination in two groups
The stomach was divided into six parts: cardia, fundus, body, antrum, angle and pylorus. The proportion of all subjects who completed complete observation of the six anatomical parts.
Measured: 2 weeks
Completion rate of small bowel examination by capsule endoscopy in two groups
Small bowel examination completion definition: All subjects reached the cecum with capsule endoscopy and completed small bowel examination.
Measured: 2 weeks
Success rate of instrument-assisted examination in the two groups
The success rate of device-assisted examination was defined as the proportion of small bowel examinations performed by endoscopists using endoscope-assisted capsules.
Measured: 2 weeks
Two groups of capsule endoscopy swallowing time
Swallowing time was defined as the time between the time when the patient first placed the capsule in the mouth and the time when the patient took the first image of the esophagus.
Measured: 2 weeks
Two groups of capsule endoscopy swallowing intake of water
Definition of water intake in swallowing capsule: The total amount of water ingested by the subject after swallowing the capsule successfully or unsuccessfully using a measuring cup.
Measured: 2 weeks
The degree of difficulty of capsule swallowing in the two groups
Swallowing difficulty is assessed on a scale of 0-5, with 0 being no difficulty and 5 being the most difficult.
Measured: 2 weeks
Factors affecting swallowing by capsule endoscopy
Physiological parameter such as BMI were recorded
Measured: 2 weeks
Factors affecting gastrointestinal retention under capsule endoscopy
The incidence of capsule retention due to anesthesia or intestinal obstruction was recorded
Measured: 2 weeks
The transmit time of esophagus, the transmit time of stomach, the transmit time of small intestine and the retention time of capsule in two groups
The time of the first esophageal image, the first stomach image, the first small intestine image, the first large intestine image and the last image taken by capsule endoscopy were recorded.
Esophageal transmit time: time of first stomach image minus time of first esophageal image Stomach transmit time: time of first small intestine image minus time of first stomach image Small bowel transmit time: the time of the first large intestine image minus the time of the first small intestine image Total retention time of the capsule in vivo: total recording time of the capsule in vivo, which is the time of the last image of the capsule minus the time of the first image of the esophagus.
Measured: 2 weeks
The time of gastric examination was magnetically controlled in the MCE group
Measured: 2 weeks
The rate of pylorus was magnetically controlled in the MCE group
Measured: 2 weeks
The detection rate of gastrointestinal lesions by capsule endoscopy in two groups
Measured: 2 weeks
Mucosal cleanliness of esophagus in two capsule endoscopy groups
Esophageal mucosa cleanliness score (Grade0: no bubbles, saliva or a small amount of bubbles, saliva, no impact on the observation of mucosa; Grade 1: moderate amount of bubbles and saliva, slight effect on observed mucosa; Grade 2: a large number of bubbles and saliva, which have a great influence on the observation of mucosa)
Measured: 2 weeks
Mucosal cleanliness of stomach in two capsule endoscopy groups
Gastric mucosa cleanliness score:（Grade 1 : no adhesive mucus and foam, clear field of vision; Grade 2 : there is a small amount of mucus and foam, but the visual field is not blurred, which does not affect the integrity of the examination; Grade 3 : medium amount of mucus and foam, blurred visual field, affecting the integrity of the examination; Grade 4 : large amount of mucus and foam, blurred vision, affecting the integrity of the examination）
Measured: 2 weeks
Mucosal cleanliness of small intestine in two capsule endoscopy groups
Small intestinal mucosa cleanliness score:
Small bowel cleanliness score (Grade0: no fecal residue or a small amount of clear fluid, clear field of vision; Grade 1: There is a small amount of fecal residue or more clear liquid, and the visual field is still clear, which does not affect the observation; Grade 2: More fecal residue or turbid fecal fluid, blurred vision, affecting observation)
Measured: 2 weeks
The integrity of esophageal mucosa was observed by capsule endoscopy in the two groups
Esophageal mucosal integrity The dentate line observation was evaluated mainly, including whether the dentate line could be observed, and the number of dentate line observation quadrants;
Measured: 2 weeks
The integrity of gastric mucosa was observed by capsule endoscopy in the two groups
Gastric mucosa integrity assessment:
The main anatomic sites such as cardia, fundus, body, Angle, antrum and pylorus were observed (grade 1: sufficient observation, ≥ 90% of gastric mucosa could be observed; Grade 2: Good observation, 70-90% of the gastric mucosa can be observed; Level 3: Insufficient observation, < 70% of gastric mucosa can be observed)
Measured: 2 weeks
The integrity of small bowel mucosa was observed by capsule endoscopy in the two groups
The percentage of the total small bowel examination time in which the mucosa was clearly visible (> 50% visual field) was recorded
Measured: 2 weeks
Incidence of adverse events
The rates of adverse events such as asphyxia by capsule aspiration, drug allergy and capsule retention were recorded
Measured: 2 weeks
Overall inspection comfort score
A questionnaire survey was conducted on the overall comfort of Normal-sized CE and Mini-sized MCE, with 4 scores as very comfortable, 3 scores as comfortable, 2 scores as tolerable, 1 score as uncomfortable, and 0 score as very uncomfortable.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start20 Oct 2022 (estimated)
- Primary completion20 Jul 2023 (estimated)
- Study completion20 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Small Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Children's Hospital, Xian Children's Hospital
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
- Investigators
- Zhuan Liao, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522101
- Sponsor's protocol ID
- Mini-sized MCE
- Status last verified
- Oct 2022
- First submitted
- 4 Aug 2022
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After finishing this study,We will make the data available to other researchers:including protocol,statistical analysis plan (SAP),informed consent form (ICF) and clinical study report (CSR).
Publications
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.
PubMed 20155845Arguelles-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.
PubMed 26671584Urs 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.
PubMed 24126830Gu 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.
PubMed 30747810Cardey 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.
PubMed 30184608Pai 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.
PubMed 31365487Oliva 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.
PubMed 24777427Xie 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.
PubMed 31205466Fritscher-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.
PubMed 19625281Radhakrishnan 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.
PubMed 33469272Ohmiya 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.
PubMed 34379849Burgess 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.
PubMed 30483526Dan 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.
PubMed 30981792Melson 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.
PubMed 33642034Jiang 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.
PubMed 31981648
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini-sized Magnetically Controlled Capsule Endoscopy vs. Normal-sized CE for Detection of Small Bowel in Children Under the Age of 10 Years：A Prospective，Multi-center，Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05522101
- Acronym / sponsor ID
- Mini-sized MCE
- Conditions
- Small Bowel Disease
- Keywords
- Children, Small Bowel Disease, Capsule Endoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Shanghai Children's Hospital, Xian Children's Hospital
- Study start
- 20 Oct 2022 (estimated)
- Primary completion
- 20 Jul 2023 (estimated)
- Study completion
- 20 Jul 2023 (estimated)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this prospective randomized controlled trial, pediatric volunteers were enrolled and randomly underwent mini-sized MCE and normal-sized CE to compare the success rate of self-swallowing between mini-sized MCE and normal-sized CE during gastrointestinal examination.
Detailed description
Magnetic controlled capsule endoscopy (MCE) is comparable to traditional gastroscopy (EGD) in the diagnosis of gastric diseases, and has been widely used in clinical practice. However, there are still some limitations in the application of MCE in digestive tract examination. Due to the large size of capsules at present, some patients have difficulty swallowing capsules during capsule swallowing, which leads to the failure of examination, and the proportion is higher in children patients. Therefore, in order to further improve the patient's comfort in swallowing capsules, our team developed a small MCE with a smaller size combined with innovation, which is 0.6 times of the conventional MCE in terms of volume and weight. This study aims to clarify the application efficacy of mini-MCE in gastrointestinal examination of adults and children through a multicenter clinical study comparing conventional capsule endoscopy with mini-magnetic-controlled capsule endoscopy. In order to ensure the efficacy of the capsule in the examination of digestive tract mucosa, and improve the ease of swallowing in children.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini-sized MCE | Experimental | Device: Mini-sized MCEAKES-31SW Capsule Endoscopy |
| Normal sized CE | Placebo comparator | Device: Normal-sized MCEPillCam Capsule Endoscopy |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients and their legal guardians agreed to participate in the study and signed informed consent;
- 2 years ≤ age < 10 years;
- Pediatric patients with suspected small bowel disease who are scheduled for small bowel capsule endoscopy
Key exclusion criteria (14 listed)
- Intestinal obstruction, stenosis, or fistula is known or suspected;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini-sized MCEAKES-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 | Device | Mini-sized MCE |
| Normal-sized MCEPillcam 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. | Device | Normal sized CE |
Primary outcome
Success rate of self-swallowing with Mini-sized MCE
Time frame: 2 weeks
Self-swallowing was defined as the subjects swallowing capsules for examination by themselves, and no endoscope or other instruments were needed to place capsules during the entire examination process
20 secondary outcomes
Completion rate of capsule endoscopy gastric examination in two groups
Time frame: 2 weeks
Completion rate of small bowel examination by capsule endoscopy in two groups
Time frame: 2 weeks
Success rate of instrument-assisted examination in the two groups
Time frame: 2 weeks
Two groups of capsule endoscopy swallowing time
Time frame: 2 weeks
Two groups of capsule endoscopy swallowing intake of water
Time frame: 2 weeks
The degree of difficulty of capsule swallowing in the two groups
Time frame: 2 weeks
Factors affecting swallowing by capsule endoscopy
Time frame: 2 weeks
Factors affecting gastrointestinal retention under capsule endoscopy
Time frame: 2 weeks
The transmit time of esophagus, the transmit time of stomach, the transmit time of small intestine and the retention time of capsule in two groups
Time frame: 2 weeks
The time of gastric examination was magnetically controlled in the MCE group
Time frame: 2 weeks
The rate of pylorus was magnetically controlled in the MCE group
Time frame: 2 weeks
The detection rate of gastrointestinal lesions by capsule endoscopy in two groups
Time frame: 2 weeks
Mucosal cleanliness of esophagus in two capsule endoscopy groups
Time frame: 2 weeks
Mucosal cleanliness of stomach in two capsule endoscopy groups
Time frame: 2 weeks
Mucosal cleanliness of small intestine in two capsule endoscopy groups
Time frame: 2 weeks
The integrity of esophageal mucosa was observed by capsule endoscopy in the two groups
Time frame: 2 weeks
The integrity of gastric mucosa was observed by capsule endoscopy in the two groups
Time frame: 2 weeks
The integrity of small bowel mucosa was observed by capsule endoscopy in the two groups
Time frame: 2 weeks
Incidence of adverse events
Time frame: 2 weeks
Overall inspection comfort score
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Background: PubMed 20155845Swaminath 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.
- Background: PubMed 26671584Arguelles-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.
- Background: PubMed 24126830Urs 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.
- Background: PubMed 30747810Gu 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.
- Background: PubMed 30184608Cardey 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.
- Background: PubMed 31365487Pai 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.
- Background: PubMed 24777427Oliva 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.
- Background: PubMed 31205466Xie 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.
- Background: PubMed 19625281Fritscher-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.
- Background: PubMed 33469272Radhakrishnan 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.
- Background: PubMed 34379849Ohmiya 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.
- Background: PubMed 30483526Burgess 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.
- Individual participant dataSharing planned: Yes. After finishing this study,We will make the data available to other researchers:including protocol,statistical analysis plan (SAP),informed consent form (ICF) and clinical study report (CSR).
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Advanced Solid Tumors, Metastatic Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhuan Liao principal investigator
Changhai Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini-sized MCE and Normal-sized MCE in people with Small Bowel Disease, run by Changhai Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhuan Liao (86-21-31161004, liaozhuan@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of self-swallowing with Mini-sized MCE (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05522101, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.