NCT07410026

Brief Summary

The aim of our study was to compare the utility and safety of SBE and DBE in pediatric patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

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 1, 2015

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
Last Updated

February 13, 2026

Status Verified

January 1, 2026

Enrollment Period

9.4 years

First QC Date

February 8, 2026

Last Update Submit

February 8, 2026

Conditions

Small Bowel Diseases

Outcome Measures

Primary Outcomes (1)

  • diagnostic yield

    Diagnostic yield was defined as the percentage of procedures with a disease-specific definitive endoscopic diagnosis.

    From Baseline to the finish of enteroscopy

Secondary Outcomes (5)

  • Positive rate

    from baseline to the finish of enterscopy

  • Complete enteroscopy

    start to the finish of the enteroscopy

  • Therapeutic yield

    frome baselin to finish of the enteroscopy

  • procedure time

    from start to finish of the enteroscopy

  • adverse events

    From first day until 30 days

Study Arms (2)

SBE group

Device: single-bollon enteroscopy

DBE group

Device: double-bollon enteroscopy

Interventions

single-bollon enteroscopyDEVICE

one group use single-balloon enteroscopy (SBE) in pediatric patients

SBE group
double-bollon enteroscopyDEVICE

one group use double-bollon enteroscopy

DBE group

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

pediatric patients (≤18 years) with suspected small bowel disease who underwent BAE

You may qualify if:

  • This study retrospectively collected clinical data and endoscopic information of pediatric patients (≤18 years) with suspected small bowel disease who underwent BAE consecutively at a tertiary medical center (Qilu Hospital of Shandong University, Jinan, China) from January 2015 to May 2024.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Qilu Hospital Gastroenterology Department

Study Record Dates

First Submitted

February 8, 2026

First Posted

February 13, 2026

Study Start

January 1, 2015

Primary Completion

May 30, 2024

Study Completion

May 30, 2024

Last Updated

February 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)