NCT03977935 is a NA clinical trial of the second-generation MCCG in Capsule Endoscopy, sponsored by Changhai Hospital.

Who is sponsoring NCT03977935?

NCT03977935 is sponsored by Changhai Hospital.

What drugs are being tested in NCT03977935?

Interventions in NCT03977935: the second-generation MCCG.

What condition does NCT03977935 study?

NCT03977935 studies Capsule Endoscopy.

Is NCT03977935 still recruiting?

NCT03977935 is currently completed. Last updated 27 October 2020.

Are results published for NCT03977935?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-10-27 · How we verify

NCT03977935

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Second-Generation MCCG for Upper Gastrointestinal Tract.

Completed NA Results posted Last updated 27 October 2020

What this trial tests

NA trial testing the second-generation MCCG in Capsule Endoscopy in 80 participants. Completed in 25 July 2019.

Timeline

10 May 2019

Primary endpoint
18 July 2019

25 July 2019

Quick facts

Lead sponsor	Changhai Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	80
Start date	10 May 2019
Primary completion	18 July 2019
Estimated completion	25 July 2019
Sites	1 location across China

Drugs / interventions tested

the second-generation MCCG

Conditions studied

Capsule Endoscopy — all drugs for Capsule Endoscopy →

Sponsor

Changhai Hospital

Who can join

Adults 18 to 80, any sex, with Capsule Endoscopy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Circumferential Visualization of the Z-line Primary · Through end of examination, up to 30 minutes

Circumferential visualization of the Z-line is defined by quadrants as follows: less than 2 quadrants (\< 50%) of the Z line observed; at least 2 quadrants (50%-75%) observed; at least 3 quadrants (\>75%) observed; and entire Z line (100%) observed.

Group	Value	95% CI
The First-generation MCCG Group	0
The Second-generation MCCG Group	5
The First-generation MCCG Group	5
The Second-generation MCCG Group	7
The First-generation MCCG Group	12
The Second-generation MCCG Group	12
The First-generation MCCG Group	23
The Second-generation MCCG Group	16

Detection Rate of Duodenal Papilla Secondary · up to 2 days after the examination

Detection rate of duodenal papilla means the percentage of patients with at least one image of duodenal papilla was obtained

Group	Value	95% CI
The First-generation MCCG Group	3
The Second-generation MCCG Group	6

Gastric Examination Time (GET) Secondary · Through end of examination, up to 30 minutes

Record the time taken for endoscopist to finish the gastric examination for primary anatomical landmarks twice (cardia, fundus, body, angulus, antrum and pylorus).

Group	Value	95% CI
The First-generation MCCG Group	7.78	± 0.97
The Second-generation MCCG Group	5.24	± 0.74

Manipulation Performance Score of the MCCG Secondary · up to 10 minutes after the examination

The performance of maneuverability is assessed using a semi-quantitative score related to the fluency, stability and comfortableness for examination procedure. Fluency is mainly reflected on the response speed to operation and smoothness of video playing. Stability is about the ability of holding the position for a long enough time and the real-time viewing of all images. comfortableness is the operator's sensation about manipulative force and fatigue degree. Maneuverability score was defined as a total scale of 3 to 15 calculated by adding up each evaluation index score above, and each index

Fluency

Group	Value	95% CI
The First-generation MCCG Group	3.04	± 0.51
The Second-generation MCCG Group	4.59	± 0.42

Comfortableness

Group	Value	95% CI
The First-generation MCCG Group	3.16	± 0.45
The Second-generation MCCG Group	4.51	± 0.43

Stability

Group	Value	95% CI
The First-generation MCCG Group	3.84	± 0.55
The Second-generation MCCG Group	4.17	± 0.50

Total score

Group	Value	95% CI
The First-generation MCCG Group	10.05	± 1.04
The Second-generation MCCG Group	13.28	± 0.9

Image Quality Score (Mainly Focus on Clarity) Secondary · up to 30 minutes after the examination

Assess Image quality grade ranged from 1 to 10 (1, the worst quality; 10, the quality of the best image captured by EGD).

Group	Value	95% CI
The First-generation MCCG Group	7.90	± 0.61
The Second-generation MCCG Group	8.63	± 0.57

The Number of Images Captured for Esophagus and Z-line Secondary · up to 30 minutes after the examination

The number of images captured by MCCG for esophagus and Z-line.

The number of images captured for esophagus

Group	Value	95% CI
The First-generation MCCG Group	97	42 – 160.25
The Second-generation MCCG Group	171	81.25 – 409.25

The number of images captured for Z-line

Group	Value	95% CI
The First-generation MCCG Group	0	0 – 2.75
The Second-generation MCCG Group	2	0 – 13.00

Number of Participants With Lesions in Upper Gastrointestinal Tract Secondary · up to 2 days after the examination

calculate the number of participants with lesions in different part of upper gastrointestinal tract (esophagus, stomach, duodenum, jejunoileum), and preliminarily evaluate the diagnostic efficacy of the new-generation MCCG.

Group	Value	95% CI
The First-generation MCCG Group	25
The Second-generation MCCG Group	24
The First-generation MCCG Group	12
The Second-generation MCCG Group	13
The First-generation MCCG Group	3
The Second-generation MCCG Group	3

Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time Secondary · up to 2 days after the examination

Assess the transit time of MCCG in the gastrointestinal tract (stomach and small bowel), and record the total running time from starts take images to ends.

Gastric transit time (min)

Group	Value	95% CI
The First-generation MCCG Group	53.09	22.88 – 90.84
The Second-generation MCCG Group	48.35	19.09 – 78.83

Small-bowel transit time (min)

Group	Value	95% CI
The First-generation MCCG Group	327.60	260.73 – 394.55
The Second-generation MCCG Group	297.22	239.68 – 369.27

Total running time (min)

Group	Value	95% CI
The First-generation MCCG Group	702.83	648.47 – 856.10
The Second-generation MCCG Group	1001.99	774.42 – 1207.38

Cleansing Level Score of Z-line Area Secondary · Through end of examination, up to 30 minutes

The bubbles/saliva on the Z line area will be scored as follows: 0 = no bubbles/saliva on the Z line area;1 = a few bubbles/saliva on the Z line area; 2= increased amount of bubbles/saliva on the Z line area; 3 = severe bubbles/saliva on the Z line area.

Group	Value	95% CI
The First-generation MCCG Group	13
The Second-generation MCCG Group	11
The First-generation MCCG Group	18
The Second-generation MCCG Group	22
The First-generation MCCG Group	7
The Second-generation MCCG Group	5
The First-generation MCCG Group	2
The Second-generation MCCG Group	2

The Incidence of Adverse Events (The Safety of MCCG) Secondary · up to 2 weeks after the examination

The presence of adverse events within two weeks aftter swallowing MCCG will be recorded.

Group	Value	95% CI
The First-generation MCCG Group	0
The Second-generation MCCG Group	0

Transit Time of MCCG in Esophagus Secondary · up to 2 days after the examination

Assess the transit time of MCCG in esophagus from starts take images to ends.

Group	Value	95% CI
The First-generation MCCG Group	59.5	24.75 – 82.75
The Second-generation MCCG Group	44.5	23.0 – 107.5

Sponsor's own description

The aim of this study is to evaluate the clinical application of the second-generation MCCG with higher image resolution and frame rate for upper gastrointestinal tract compared with the first-generation.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Second-generation magnetically controlled capsule gastroscopy with improved image resolution and frame rate: a randomized controlled clinical trial (with video).
Jiang B, Qian YY, Pan J, Jiang X, et al · · 2020 · cited 24× · PMID 31981648 · DOI 10.1016/j.gie.2020.01.027

Verify or expand the search:

Other recruiting trials for Capsule Endoscopy

Currently open trials in the same condition.

NCT07325344 — Active Locomotion of Magnetically Controlled Capsule Endoscopy in the Small Bowel: A Feasibility Study · NA · recruiting

Other Changhai Hospital trials

Trials by the same sponsor.

NCT07490002 — Neoadjuvant Therapy With Iparomlimab and Tuvonralimab, Lenvatinib and Chemotherapy in Resectable ESCC · Phase 2 · not yet recruiting
NCT07464392 — FMT for the Prevention of Infectious Complications in Patients With Moderately Severe and Severe Acute Pancreatitis · NA · recruiting
NCT07507071 — Comparison of the Sensitivity of pCLE and Pathological Biopsy for Gastric Mucosal Lesions · not yet recruiting
NCT07481591 — Capsule Endoscopy in GI Bleeding: A Retrospective Study · not yet recruiting
NCT07439757 — AI-Powered Precision Decision-Making for Pancreatic Diseases · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03977935 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Changhai Hospital
Last refreshed: 27 October 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03977935.

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