Clinical trial Recruiting at 6 sites Interventional Ages 18 and up

Comparing one-person and two-person techniques in single-balloon enteroscopy

Official title: Single-operator Versus Two-operator Technique in Single-balloon Enteroscopy: a Prospective, Multicenter, Non-inferiority Randomized Controlled Trial

Run by Xijing Hospital of Digestive Diseases · NCT06280469 · Data updated 2026-11-12

This study is testing whether one doctor can do a small bowel procedure more effectively and comfortably for patients than two doctors working together.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment228 (estimated)
SponsorXijing Hospital of Digestive Diseases
Academic / other
Locations6 sites (Lanzhou, Gansu and 5 other locations)
StatusRecruiting
StartedMay 1, 2024
Main results expectedNovember 2026
Study endsDecember 2026
Registry record updatedSeptember 9, 2026
Trial IDNCT06280469 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults over 18 years old who have suspected small bowel disease and are scheduled for enteroscopy.

Probably not a fit

Patients with a history of small bowel surgery or those who are not suitable for general anesthesia may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares the effectiveness of single-operator versus double-operator techniques in single-balloon enteroscopy for diagnosing and treating small bowel diseases. It aims to evaluate whether a single operator can provide better observation and treatment of lesions, reduce examination time, and minimize postoperative discomfort compared to a two-person approach. The study will involve patients suspected of having small bowel disease and will assess the depth of insertion and overall examination quality. By focusing on a more efficient method, the study seeks to optimize resource use in endoscopy rooms.

Why it matters

Potential benefit: If successful, this approach could lead to more efficient and comfortable procedures for patients with small bowel diseases.

How similar studies have gone: While there is limited comparative research on single versus double-operator techniques in single-balloon enteroscopy, the approach of optimizing procedural efficiency is gaining interest in the field.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* age greater than eighteen years;
* suspected small bowel disease with planned enteroscopy

Exclusion Criteria:

* patients with a history of small bowel surgery;
* patients who fail to perform bowel preparation as required;
* patients with existing esophageal varices at high risk of bleeding;
* patients not requiring a deep small-bowel examination, such as those with lesions clearly localized to the proximal jejunum, or terminal ileum;
* patients who are in extremely poor physical condition and are not suitable for general anesthesia, as defined by an ASA score greater than 3;
* pregnant or lactating women;
* patients unable to provide written informed consent.

Where it's running

  • The First Hospital of Lanzhou University
    Lanzhou, Gansu, China
    Recruiting
  • The Second Hospital & Clinical Medical School, Lanzhou University
    Lanzhou, Gansu, China
    Recruiting
  • The Fifth Affiliated Hospital of Zunyi Medical University
    Zhuhai, Guangdong, China
    Recruiting
  • The Second Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shannxi, China
    Recruiting
  • Xi'an Honghui Hospital
    Xi'an, Shannxi, China
    Recruiting
  • Xijing Hospital of Digestive Diseases
    Xi'an, Shannxi, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.