NCT05073536

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 11, 2021

Completed
Last Updated

November 10, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

September 17, 2021

Last Update Submit

November 7, 2022

Conditions

Capsule Endoscopy

Keywords

magnetically controlled capsule endoscopy

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (7)

  • the number of images captured for Z-line and quadrants of the Z-line

    6 months

  • Visualization score of the gastric mucosa

    6 months

  • Visualization of the small bowel

    6 months

  • Difficulty score of swallowing the capsule

    1 month

  • Gastrointestinal transit time

    1 month

  • +2 more secondary outcomes

Study Arms (2)

mini-sized MCE

EXPERIMENTAL

Participants in this group underwent examination of mini-sized MCE.

Device: mini-sized MCE

normal-sized MCE

OTHER

Participants in this group underwent examination of normal-sized MCE.

Device: normal-sized MCE

Interventions

mini-sized MCEDEVICE

Enrolled participants were randomly allocated into the normal-sized MCE group or mini-sized MCE group in a 1:1 ratio.

mini-sized MCE
normal-sized MCEDEVICE

Enrolled participants were randomly allocated into the normal-sized MCE group or mini-sized MCE group in a 1:1 ratio.

normal-sized MCE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients aged ≥18.
  • Scheduled to undergo a capsule endoscopy for both stomach and small bowel.
  • Signed the informed consents before joining this study.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, 200433, China

Location

Related Publications (9)

  • 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.

    PMID: 27211503BACKGROUND

  • 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.

    PMID: 30367341BACKGROUND

  • 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. No abstract available.

    PMID: 31194028BACKGROUND

  • 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.

    PMID: 30005825BACKGROUND

  • 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.

    PMID: 31328998BACKGROUND

  • Nuutinen H, Kolho KL, Salminen P, Rintala R, Koskenpato J, Koivusalo A, Sipponen T, Farkkila 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.

    PMID: 21615227BACKGROUND

  • 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.

    PMID: 25896843BACKGROUND

  • 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.

    PMID: 30981792BACKGROUND

  • Jiang X, Qiu XO, Li Z, Pan J, Peng C, Zuo XL, Liao Z, Li ZS. Small-sized versus standard magnetic capsule endoscopy in adults: a two-center, double-blinded randomized controlled trial. Endoscopy. 2023 Jan;55(1):52-57. doi: 10.1055/a-1881-4369. Epub 2022 Jul 12.

    PMID: 35820437DERIVED

Study Officials

  • Zhuan Liao, Professor

    Changhai Hospital,Shanghai,China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 17, 2021

First Posted

October 11, 2021

Study Start

January 12, 2021

Primary Completion

May 30, 2021

Study Completion

September 15, 2021

Last Updated

November 10, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)