Double-balloon EnteroscopyNCT07288346
Effect of Predictive Model on Double-Balloon Enteroscopy
A study testing Predictive model in people with Double-balloon Enteroscopy, run by Shandong University at 5 sites in China.
Trial summary
The aim of this study is to assess the effect of predictive model on total enteroscopy rate in double-balloon enteroscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Double-balloon Enteroscopy
- What is being tested?
- Predictive model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 5 sitesChina
- Study dates
- 12 Jan 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged between 18 and 80 years who were planned to undergo an attempt at total enteroscopy for suspected small-bowel disease
- CT scan of the abdomen was performed within two weeks before enteroscopy
Who cannot join
- cases terminated upon the target lesion (strictures, masses, hemorrhagic or other lesions) and not the maximal insertion
- poor quality of bowel preparation
- high risk esophageal varices
- the insertion route is not oral or anal because of changes in anatomical structure
- unsuitable for general anesthesia
- pregnant women
- unable to provide informed consent
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Dezhou People's Hospital
Dezhou, Shandong
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shangdong
- Recruiting
Qilu Hospital of Shandong University (Qingdao)
Qingdao, Shandong
- Recruiting
Yantai Affiliated Hospital of Binzhou Medical University
Yantai, Shandong
- Recruiting
Zaozhuang Municipal Hospital
Zaozhuang, Shandong
About this study
Official title: Effect of Predictive Model on Total Double-Balloon Enteroscopy Rate: a Randomized Controlled Trial
The aim of this study is to assess the effect of predictive model on total enteroscopy rate in double-balloon enteroscopy.
Read the detailed description
Double-balloon enteroscopy is a new and effective endoscopic technique used for the diagnosis and treatment of small intestinal diseases. Due to its deep intubation ability, it can achieve complete visualization of the small intestinal mucosa, that is, total enteroscopy. Theoretically, a higher total enteroscopy rate could be associated with a greater possibility of detecting positive lesions. However, a total enteroscopy is a challenging procedure for endoscopists. Endoscopists cannot accurately predict the operational difficulty of patients before the operation, which leads to the passivity of preoperative preparation and intraoperative strategy formulation.
Recently, the Department of Gastroenterology of Qilu Hospital of Shandong University has completed the development and external validation of the first double-balloon enteroscopy prediction model. A preoperative individualized assessment of the difficulty of total enteroscopy can be achieved using this model. Therefore, a multicenter randomized controlled study was designed to assess the performance of predictive model in double-balloon enteroscopy, including total enteroscopy rate, positive findings, procedural time, adverse events and other indicators.
- Conditions
- Double-balloon Enteroscopy
- Being tested
- Predictive model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Predictive modelOther
Endoscopists obtain the patient's predictive model scores before double-balloon enteroscopy.
| Study group | Role | What they receive |
|---|---|---|
| Predictive model group | Experimental | Endoscopists will obtain the predictive model intervention. Receives: Other: Predictive model |
| Control group | No intervention | Endoscopists will not obtain the predictive model intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total enteroscopy rate
Total enteroscopy rate was defined as the number of patients with complete visualization of the small bowel divided by the total number of patients.
Measured: 8 months
Secondary outcomes (3)
Diagnostic yield
Positive findings included vascular malformation, ulcer, polyp, diverticulum and others.
Measured: 8 months
Procedural time
The total time of antegrade and retrograde insertions
Measured: 8 months
Adverse events
Adverse reactions refer to bleeding, perforation, aspiration pneumonia, acute pancreatitis and other conditions related to double-balloon enteroscopy.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start12 Jan 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Double-balloon EnteroscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Hospital of Shandong University (Qingdao), Dezhou People's Hospital, Yantai Affiliated Hospital of Binzhou Medical University, Zaozhuang Municipal Hospital
- Responsible party
- Principal investigator, Xiuli Zuo, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288346
- Sponsor's protocol ID
- QLCR20250630
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Predictive Model on Total Double-Balloon Enteroscopy Rate: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07288346
- Acronym / sponsor ID
- QLCR20250630
- Conditions
- Double-balloon Enteroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Qilu Hospital of Shandong University (Qingdao), Dezhou People's Hospital, Yantai Affiliated Hospital of Binzhou Medical University, Zaozhuang Municipal Hospital
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the effect of predictive model on total enteroscopy rate in double-balloon enteroscopy.
Detailed description
Double-balloon enteroscopy is a new and effective endoscopic technique used for the diagnosis and treatment of small intestinal diseases. Due to its deep intubation ability, it can achieve complete visualization of the small intestinal mucosa, that is, total enteroscopy. Theoretically, a higher total enteroscopy rate could be associated with a greater possibility of detecting positive lesions. However, a total enteroscopy is a challenging procedure for endoscopists. Endoscopists cannot accurately predict the operational difficulty of patients before the operation, which leads to the passivity of preoperative preparation and intraoperative strategy formulation.
Recently, the Department of Gastroenterology of Qilu Hospital of Shandong University has completed the development and external validation of the first double-balloon enteroscopy prediction model. A preoperative individualized assessment of the difficulty of total enteroscopy can be achieved using this model. Therefore, a multicenter randomized controlled study was designed to assess the performance of predictive model in double-balloon enteroscopy, including total enteroscopy rate, positive findings, procedural time, adverse events and other indicators.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Predictive model group | Experimental | Other: Predictive modelEndoscopists will obtain the predictive model intervention. |
| Control group | No intervention | –Endoscopists will not obtain the predictive model intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged between 18 and 80 years who were planned to undergo an attempt at total enteroscopy for suspected small-bowel disease
- CT scan of the abdomen was performed within two weeks before enteroscopy
Key exclusion criteria (7 listed)
- cases terminated upon the target lesion (strictures, masses, hemorrhagic or other lesions) and not the maximal insertion
- poor quality of bowel preparation
- high risk esophageal varices
- the insertion route is not oral or anal because of changes in anatomical structure
- unsuitable for general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Predictive modelEndoscopists obtain the patient's predictive model scores before double-balloon enteroscopy. | Other | Predictive model group |
Primary outcome
Total enteroscopy rate
Time frame: 8 months
Total enteroscopy rate was defined as the number of patients with complete visualization of the small bowel divided by the total number of patients.
3 secondary outcomes
Diagnostic yield
Time frame: 8 months
Procedural time
Time frame: 8 months
Adverse events
Time frame: 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Predictive model in people with Double-balloon Enteroscopy, run by Shandong University at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiuli Zuo (86-0531-82165292, xiulizuo@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total enteroscopy rate (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.