Capsule Endoscopy Clinical Trial
Official title:
Detachable String Magnetically Controlled Capsule Endoscopy for Complete Examination of Upper Gastrointestinal Tract and Small Bowel
Verified date | March 2020 |
Source | Changhai Hospital |
Contact | Bin Jiang |
Phone | 15021569528 |
jarz1995[@]163.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to evaluate the feasibility and safety of DS-MCE with a novel way for complete examination in UGI tract and small bowel, compared with EGD.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | September 20, 2020 |
Est. primary completion date | August 20, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Adult patients aged 18 to 80 2. With or without gastrointestinal complaints 3. Scheduled to undergo a capsule endoscopy for both stomach and small bowel 4. Signed the informed consents before joining this study Exclusion Criteria: 1. Pacemakers or electromedical devices implanted which are incompatible with magnetic field; 2. Suspected or known gastrointestinal stenosis, obstruction or other known risk factors for capsule retention; 3. Scheduled magnetic resonance imaging examination before excretion of capsule; 4. Pregnancy or suspected pregnancy; 5. Any contraindications about EGD. 6. Other circumstances that doctors consider inappropriate for the study. |
Country | Name | City | State |
---|---|---|---|
China | Changhai Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Zhuan Liao |
China,
Chen YZ, Pan J, Luo YY, Jiang X, Zou WB, Qian YY, Zhou W, Liu X, Li ZS, Liao Z. Detachable string magnetically controlled capsule endoscopy for complete viewing of the esophagus and stomach. Endoscopy. 2019 Apr;51(4):360-364. doi: 10.1055/a-0856-6845. Epub 2019 Mar 1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Success rate of UGI and small-bowel examination | The feasibility of DS-MCE examination with a novel way is evaluated by the technical success rate, a composite outcome including the successful separation of the string and MCE, repeat viewing of esophagus, stomach and duodenum, and complete small-bowel examination. | up to 2 weeks | |
Secondary | Diagnostic accuracy | The diagnostic accordance rate, sensitivity and specificity of lesions detected by DS-MCE compared with EGD. | up to 2 weeks | |
Secondary | Safety of DS-MCE procedure: presence of any adverse events during DS-MCE procedure will be recorded | The presence of any adverse events during DS-MCE procedure will be recorded. | up to 2 weeks | |
Secondary | Detection rate of Z-line, duodenal papilla and pyloric retrograde view | The detection means that at least one image of anatomical structure was obtained. | up to 2 weeks | |
Secondary | Circumferential visualization of the Z-line and duodenal papilla | It is defined by quadrants as follows: less than 2 quadrants (< 50%) observed; at least 2 quadrants (50%-75%) observed; at least 3 quadrants (>75%) observed; and entire structure (100%) observed. | up to 2 weeks | |
Secondary | Cleansing level of Z-line and duodenal papilla area | The effect of bubbles/saliva on the appearance of the Z line or duodenal papilla area was both scored as follows: 0=no interference by bubbles/saliva;1=minor interference of bubbles/saliva; 2=major interference of bubbles/saliva. | up to 2 weeks | |
Secondary | Visualization level of stomach | Visualization level of gastric primary anatomic landmarks: cardia, fundus, body, angulus, antrum and pylorus. (good, >75% of mucosa was observed; moderate, 50% to 75% was observed; poor, <50% of the gastric mucosa was observed) | up to 2 weeks | |
Secondary | Examination time of esophagus, stomach, duodenum and small bowel | Record the time taken to finish examination in different digestive part. | up to 2 weeks | |
Secondary | Pyloric transit time | Record the time from completion of the gastric examination to the capsule entering the duodenum. | up to 2 weeks | |
Secondary | Discomfort scores associated with DS-MCE | Discomfort caused by the string, swallowing the DS-MCE, pulling the capsule up or down, and pulling the string out were on a scale from 0 to 3 (0=none;1=mild/minimal; 2=moderate; and 3=severe/very difficult) according to the Ramirez system. Overall discomfort was scored on a scale of 0 to 10 (0=no discomfort; 10=the overall discomfort of EGD) according to our previous system. | up to 2 weeks | |
Secondary | Image quality scores | Assess Image quality grade ranged from 1 to 10 (1, the worst quality; 10, the quality of the best image captured by EGD). | up to 2 weeks | |
Secondary | Detection rate of lesions | The detection rate of lesions in different digestive part (esophagus, stomach, duodenum, jejunoileum) found by MCE. | up to 2 weeks |
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 |
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 |
NCT05073536 -
Mini-sized MCE for Better Examination of UGI and Small Bowel
|
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 |