Capsule Endoscopy Clinical Trial
Official title:
Feasibility of Mini-sized Magnetically Controlled Capsule Endoscopy in Visualization of UGI and Small Bowel: a Randomized Controlled Clinical Trial
Verified date | November 2022 |
Source | Changhai Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A mini-sized MCE highlighted with a diameter of 9.5mm, a length of 24.5mm, and a weight of 3.0g has been developed. This new type of MCE is approximately 0.6 times the conventional MCE (27mm*11.8mm) in volume and weight, and it is the smallest CE among all the reported capsules. Thus, this pilot study was conducted to clarify whether the mini-sized MCE can further optimize the process of swallowing the capsule and to verify whether the smaller size of the capsule will have influence on the examination procedure of the upper gastrointestinal tract and small intestine.
Status | Completed |
Enrollment | 96 |
Est. completion date | September 15, 2021 |
Est. primary completion date | May 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patients aged =18. - Scheduled to undergo a capsule endoscopy for both stomach and small bowel. - Signed the informed consents before joining this study. Exclusion Criteria: - Dysphagia or symptoms of gastric outlet obstruction - Known or suspected GI obstruction, stenosis, or fistula - History of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy - Implanted pacemaker, except the pacemaker is compatible with MRI - Other implanted electromedical devices or magnetic metal foreign bodies - Pregnancy or suspected pregnancy |
Country | Name | City | State |
---|---|---|---|
China | Changhai Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Changhai Hospital | Qilu Hospital of Shandong University |
China,
Dan T, Dandan S, Enqiang L. Aspiration of a magnetically controlled capsule endoscopy. Gastroenterology. 2019 Apr 11. pii: S0016-5085(19)35686-0. doi: 10.1053/j.gastro.2019.04.006. [Epub ahead of print] — View Citation
Hu J, Wang S, Ma W, Pan D, Sun S. Magnetically controlled capsule endoscopy as the first-line examination for high-risk patients for the standard gastroscopy: a preliminary study. Scand J Gastroenterol. 2019 Jul;54(7):934-937. doi: 10.1080/00365521.2019.1638446. Epub 2019 Jul 22. — View Citation
Jiang X, Pan J, Li ZS, Liao Z. Standardized examination procedure of magnetically controlled capsule endoscopy. VideoGIE. 2019 May 30;4(6):239-243. doi: 10.1016/j.vgie.2019.03.003. eCollection 2019 Jun. — View Citation
Jiang X, Qian YY, Liu X, Pan J, Zou WB, Zhou W, Luo YY, Chen YZ, Li ZS, Liao Z. Impact of magnetic steering on gastric transit time of a capsule endoscopy (with video). Gastrointest Endosc. 2018 Oct;88(4):746-754. doi: 10.1016/j.gie.2018.06.031. Epub 2018 Jul 11. — View Citation
Liao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20. — View Citation
Liao Z, Zou W, Li ZS. Clinical application of magnetically controlled capsule gastroscopy in gastric disease diagnosis: recent advances. Sci China Life Sci. 2018 Nov;61(11):1304-1309. doi: 10.1007/s11427-018-9353-5. Epub 2018 Oct 18. Review. — View Citation
Nuutinen H, Kolho KL, Salminen P, Rintala R, Koskenpato J, Koivusalo A, Sipponen T, Färkkilä M. Capsule endoscopy in pediatric patients: technique and results in our first 100 consecutive children. Scand J Gastroenterol. 2011 Sep;46(9):1138-43. doi: 10.3109/00365521.2011.584900. Epub 2011 May 26. — View Citation
Patel A, Jacobsen L, Jhaveri R, Bradford KK. Effectiveness of pediatric pill swallowing interventions: a systematic review. Pediatrics. 2015 May;135(5):883-9. doi: 10.1542/peds.2014-2114. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the difficulty score for swallowing the capsule | The primary outcome was the difficulty score for swallowing the capsule, which was assessed on a visual analog scale ranging from 0 (very easy with no nausea) to 10 (very difficult or with severe nausea) | 6 months | |
Primary | the time required to swallow the capsule | The capsule swallowing time was defined as the time between the first mouth image and the first esophageal image. | 6 months | |
Primary | the success rate for swallowing the capsule at the first attempt | If the patient swallowed the capsule directly with a sip of water at the first attempt, it was defined as a success for swallowing the capsule at the first attempt; if the capsule entered the esophagus after several swallowing attempts or with endoscopic placement, it was defined as a failure. | 6 months | |
Secondary | the number of images captured for Z-line and quadrants of the Z-line | Visualization of the esophagus indicated by the number of images captured for Z-line and how many quadrants of the Z-line were observed. | 6 months | |
Secondary | Visualization score of the gastric mucosa | To objectively evaluate the complete visualization of the gastric mucosa in the 6 anatomic landmarks (cardia, fundus, body, angulus, antrum, and pylorus), a 3-point grading scale was used: 1, poor (<70% of the mucosa was observed), 2, fair (70%-90% of the mucosa was observed), and 3, good (>90% of the mucosa was observed). | 6 months | |
Secondary | Visualization of the small bowel | Visualization of the small bowel was determined by the small bowel complete examination rate. | 6 months | |
Secondary | Difficulty score of swallowing the capsule | To evaluate the difficulty score of swallowing the capsule. After the examination, the patient was asked to complete a questionnaire. A visual analogue scale ranging from 0 (easy with no nausea) to 10 (very difficult or with sever nausea) was used to evaluate the degree of difficulty of swallowing the capsule. | 1 month | |
Secondary | Gastrointestinal transit time | Examination-related parameters included esophageal transit time (ETT), gastric examination time (GET), gastric transit time (GTT), pylorus transit time (PTT), small bowel transit time (SBTT). ETT is defined as the time between the first esophageal image and the first gastric image. GTT is defined as the time between the first gastric image and the first duodenal image. GET is defined as the time for examination of gastric primary anatomic landmarks twice. PTT is defined as the time between the first pyloric image and the first duodenal image. SBTT is defined as the time between the first duodenal image and the first cecal image. | 1 month | |
Secondary | Detection rate of lesions | The detection rate of lesions in different digestive part (esophagus, stomach, duodenum, small intestine) found by mini-sized MCE and normal-sized MCE. | 1 month | |
Secondary | Safety of mini-sized MCE procedure:presence of any adverse events during mini-sized MCE procedure will be recorded | presence of any adverse events during mini-sized MCE procedure will be recorded | 1 month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02158260 -
A New Method To Reduce Gastric Missing Areas in Capsule Endoscopy
|
N/A | |
Completed |
NCT04605536 -
Effect of Animation Video on the Success Rate of Children Swallowing Capsule Endoscopy
|
N/A | |
Completed |
NCT04327869 -
MCE Direct Visualization of Drug Behavior in Upper-gastrointestinal Tract
|
||
Recruiting |
NCT03351972 -
Differences in Preparation for Small Bowel Capsule Endoscopy
|
Phase 4 | |
Recruiting |
NCT01783782 -
Small Bowel Cleansing for Capsule Endoscopy in Pediatric Patients
|
Phase 4 | |
Completed |
NCT04671264 -
Efficacy and Safety of Vibrating Capsule in Patients With Functional Constipation
|
N/A | |
Completed |
NCT03662113 -
Effect of Domperidone on Completion Rate of Vedio Capsule Endoscopy
|
N/A | |
Completed |
NCT03977935 -
The Second-Generation MCCG for Upper Gastrointestinal Tract.
|
N/A | |
Recruiting |
NCT03441945 -
Magnetic Steering Enhance Capsule Gastroscopy Gastric Emptying
|
N/A | |
Completed |
NCT04389333 -
Feasibility of Non-contact Magnetically-controlled Capsule Endoscopy During COVID-19 Pandemic
|
N/A | |
Recruiting |
NCT04329468 -
Detachable String MCE for Upper Gastrointestinal Tract and Small Bowel
|
N/A | |
Recruiting |
NCT04933643 -
Analysis of Influencing Factors of Gastric Preparation Quality for MCCG
|
||
Completed |
NCT03482661 -
Magnetic Steering Improves Small Bowel Capsule Endoscopy Completion Rate
|
N/A | |
Recruiting |
NCT04970277 -
Efficacy of Drinking Water During Capsule Endoscopy
|
N/A | |
Completed |
NCT03742934 -
Short Peptide Formula for Bowel Preparation
|
N/A | |
Completed |
NCT05228379 -
Small Bowel Capsule Endoscopy: Experience From a Single Large Tertiary Care Centre
|
||
Recruiting |
NCT05249933 -
Pronase Granules in Gastric Cleaning
|
Phase 2/Phase 3 | |
Completed |
NCT02382705 -
SB3 Battery Life Observational Study
|
||
Recruiting |
NCT04032353 -
Medical Consortium for Screening Upper Gastrointestinal Cancers With Magnetically Controlled Capsule Gastroscopy
|
N/A | |
Completed |
NCT04479423 -
The Usage of Soda-Water in Gastric Preparation for Magnetically Controlled Capsule Endoscopy
|
N/A |