MCE-new for Detection of Gastric Lesions

Capsule Endoscopy Clinical Trial

Official title:

New MCE System for Detection of Gastric Lesions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06020859
• Other study ID #: MCE-new
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 30, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: August 2023
• Source: Changhai Hospital
• Contact: Zhuan Liao
• Phone: 86-21-31161004
• Email: liaozhuan[@]smmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clinical application of magnetically controlled capsule endoscopy : a prospective self-controlled trial

Description:

The aim of this study is to investigate the effectiveness and safety of using a new MCE system for routine gastric examination and automatic scanning. This study is a prospective, self controlled clinical trail, which includes adult patients who plan to undergo MCE examination. Patients will undergo three different tests during the experiment: NaviEC-2000Pro Gastro Scan, NaviEC-2000Pro routine gastric examination, NaviEC-1000 routine gastric examination.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• underwent gastric examination;
• At least 18 years old;
• Be able to provide informed consent.

Exclusion Criteria:

• With swallowing obstruction or disorders;
• With known or suspected gastrointestinal obstruction, stenosis and fistula;
• Have no conditions for surgery or refuse to undergo any abdominal surgery;
• Be allergic to or have other known contraindication or intolerance to the drug used in the study;
• With pacemakers or other electronic devices such as electronic cochlear implants, implanted magnetic metal drug infusion pumps, neurostimulators, and magnetic metal foreign bodies;
• Women during pregnancy;
• Currently enrolled in another clinical trial of a drug or device;
• Other conditions determined by the investigator to be inappropriate for enrollment.

Related Conditions & MeSH terms

• Capsule Endoscopy

Intervention

Device:
• undergo NaviEC-2000Pro Gastro Scan mode
Patients undergo NaviEC-2000Pro Gastro Scan mode.
• NaviEC-2000Pro Routine gastric examination
Patients undergo NaviEC-2000Pro Routine gastric examination mode.
• NaviEC-1000 Routine gastric examination
Patients undergo NaviEC-1000 Routine gastric examination mode.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

References & Publications (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the degree of gastric mucosal visualization	The overall observational integrity of the gastric mucosa is based on the evaluation of the mucosal visualization of several key anatomical sites in the stomach: cardia, fundus, gastric body, gastric horn, gastric antrum and pylorus. The evaluation criteria for mucosal visualization of each site are: good : adequate observation, =90% of the gastric mucosa can be observed; fair : good observation, 70-90% of the gastric mucosa can be observed; poor : inadequate observation, <70% of the gastric mucosa can be observed.	2 weeks
Secondary	The time of gastric examination	The total time MCE required to complete the stomach examination	2 weeks
Secondary	detection of lesions	The detection of gastric lesions by MCE	2 weeks
Secondary	Equipment operation evaluation	Operation fluency is defined as the smooth response between operation and real-time capsule shooting. Stability is defined as the stable ability to control the capsule in a fixed position; Comfort is defined as the operator's operating comfort during examination. They were all rated on a scale of 1-5, with 1 being the worst and 5 the best	2 weeks
Secondary	Safety Assessment	Number and incidence of device-related adverse events and serious adverse events	2 weeks