Phytobezoar; IntestineNCT06877559
Balloon-Assisted Enteroscopic Treatment for Phytobezoar
An observational study of Phytobezoar; Intestine, run by Shandong University at 1 site in China.
Trial summary
By reviewing a case series of patients who underwent balloon-assisted enteroscopic treatment for phytobezoar at our hospital, we analyzed the safety and efficacy of this technique. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Phytobezoar; Intestine
- What is being tested?
- balloon-assisted enteroscopic treatment for phytobezoar
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 1 Jul 2025
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: patients with small intestinal phytobezoar
Who may be able to join
- Retrospectively collect data from patients who underwent balloon-assisted enteroscopic treatment for phytobezoar at our hospital.
Who cannot join
- Patients with incomplete clinical data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Safety and Efficacy of Balloon-Assisted Enteroscopic Treatment for Phytobezoar
By reviewing a case series of patients who underwent balloon-assisted enteroscopic treatment for phytobezoar at our hospital, we analyzed the safety and efficacy of this technique.
- Conditions
- Phytobezoar; Intestine
- Being tested
- balloon-assisted enteroscopic treatment for phytobezoar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balloon-assisted enteroscopic treatment for phytobezoarOther
The endoscopists applied balloon-assisted enteroscopy for the treatment of the phytobezoar
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent balloon-assisted enteroscopic treatment for phytobezoar | Patient information was retrieved and collected through the HIS (Hospital Information System) and endoscopy system of Qilu Hospital of Shandong University, followed by statistical analysis. The collected information includes: gender, age, comorbid conditions, symptoms, time of onset, laboratory test results, time of small intestinal endoscopy, description of endoscopic procedures, success of the procedure, whether sodium bicarbonate was injected, presence of complications during treatment, length of hospital stay, and days from surgery to discharge. Receives: Other: balloon-assisted enteroscopic treatment for phytobezoar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Balloon-Assisted Enteroscopic treatment for Phytobezoar
Success Rate of the Procedure
Measured: 3 months
Secondary outcomes (1)
Safety of Balloon-Assisted Enteroscopic treatment for Phytobezoar
Incidence of Complications
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Dec 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phytobezoar; IntestineStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Zuo, Shandong University
- Investigators
- Xiuli Zuo, Study director, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877559
- Sponsor's protocol ID
- 2025-SDU-Qilu-02
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Safety and Efficacy of Balloon-Assisted Enteroscopic Treatment for Phytobezoar
- ClinicalTrials.gov ID
- NCT06877559
- Acronym / sponsor ID
- 2025-SDU-Qilu-02
- Conditions
- Phytobezoar; Intestine
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 14 Mar 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.
By reviewing a case series of patients who underwent balloon-assisted enteroscopic treatment for phytobezoar at our hospital, we analyzed the safety and efficacy of this technique.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent balloon-assisted enteroscopic treatment for phytobezoar | – | Other: balloon-assisted enteroscopic treatment for phytobezoarPatient information was retrieved and collected through the HIS (Hospital Information System) and endoscopy system of Qilu Hospital of Shandong University, followed by statistical analysis. The collected information includes: gender, age, comorbid conditions, symptoms, time of onset, laboratory test results, time of small intestinal endoscopy, description of endoscopic procedures, success of the procedure, whether sodium bicarbonate was injected, presence of complications during treatment, length of hospital stay, and days from surgery to discharge. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients with small intestinal phytobezoar
Key inclusion criteria (1 listed)
- Retrospectively collect data from patients who underwent balloon-assisted enteroscopic treatment for phytobezoar at our hospital.
Key exclusion criteria (1 listed)
- Patients with incomplete clinical data.
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 |
|---|---|---|
| balloon-assisted enteroscopic treatment for phytobezoarThe endoscopists applied balloon-assisted enteroscopy for the treatment of the phytobezoar | Other | Patients who underwent balloon-assisted enteroscopic treatment for phytobezoar |
Primary outcome
Efficacy of Balloon-Assisted Enteroscopic treatment for Phytobezoar
Time frame: 3 months
Success Rate of the Procedure
1 secondary outcome
Safety of Balloon-Assisted Enteroscopic treatment for Phytobezoar
Time frame: 3 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 14 Mar 2025.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Xiuli Zuo study director
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Phytobezoar; Intestine, run by Shandong University at 1 site 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Balloon-Assisted Enteroscopic treatment for Phytobezoar (time frame: 3 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 14 Mar 2025.