Quality of Small Bowel PreparationNCT06099392
The Effect of Transcutaneous Electrical Acustimulation on Small Bowel Preparation for Capsule Endoscopy
A study testing digital stimulators (SNM-FDC01, Ningbo MaidaMedical Device, Inc, Ningbo, China) in people with Quality of Small Bowel Preparation, run by Shanghai Changzheng Hospital.
Trial summary
Transcutaneous elctroacupuncture(TEA) at ST36 can improve gastrointestinal motility. Therefore,the investigators hypothesized that if TEA is applied to the preparation of small bowel capsule endoscopy, the small bowel peristalsis of patients can be regulated by electrical stimulation at (ST36). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Small Bowel Preparation
- What is being tested?
- digital stimulators (SNM-FDC01, Ningbo MaidaMedical Device, Inc, Ningbo, China)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Agree to sign an informed consent form; Aged 18 to 75 years old Plan to undergo small bowel capsule endoscopy;
Who cannot join
- Clinical diagnosis of gastrointestinal stricture, bowel obstruction, gastrointestinal fistula, intestinal resection; Clinical diagnosis of dysphagia; Those who require fasting or parenteral nutrition support treatment; Individuals with gastrointestinal motility disorders; Oral administration of gastrointestinal motility drugs within 1 week; Implanting medical electronic devices; Those who are allergic to compound polyethylene glycol electrolyte powder and dimethicone oil and cannot tolerate oral laxatives for intestinal preparation; Skin diseases that affect electrode fixation; Pregnant, preparing to conceive, or breastfeeding patients; Familiar with acupuncture and moxibustion treatment, acupoint selection or meridians; Researchers believe that it is not suitable for participants.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Transcutaneous Electrical Acustimulation Combined With Polyethylene Glycol-electrolyte on the Quality of Small Bowel Preparation for Capsule Endoscopy
Transcutaneous elctroacupuncture(TEA) at ST36 can improve gastrointestinal motility. Therefore,the investigators hypothesized that if TEA is applied to the preparation of small bowel capsule endoscopy, the small bowel peristalsis of patients can be regulated by electrical stimulation at (ST36). On the one hand, it can be used in combination with compound polyethylene glycol electrolyte powder, which is conducive to the discharge of small bowel contents and improve the imaging quality. On the other hand, it can improve the diagnostic rate by adjusting the intestinal transit time, And the completion rate of the examination can be improved by accelerating the gastric emptying time of capsule endoscopy.
Therefore, in order to explore the effect of TEA stimulation at ST36 combined with polyethylene glycol powder on preparation for small bowel capsule endoscopy, the investigators designed this study.
- Conditions
- Quality of Small Bowel Preparation
- Being tested
- digital stimulators (SNM-FDC01, Ningbo MaidaMedical Device, Inc, Ningbo, China)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital stimulators (SNM-FDC01, Ningbo MaidaMedical Device, Inc, Ningbo, China)Device
TEA at Zusanli(ST 36) 45 min when drinking Polyethylene Glycol Electrolytes Powder
| Study group | Role | What they receive |
|---|---|---|
| TEA group | Experimental | TEA at ST36 (Zusanli) combined with 2L Polyethylene Glycol Electrolytes Powder for bowel preparation Receives: Device: digital stimulators (SNM-FDC01, Ningbo MaidaMedical Device, Inc, Ningbo, China) |
| Sham-TEA group | No intervention | 2L Polyethylene Glycol Electrolytes Powder for bowel preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of "adequate" cleansing of the small intestine
The rate of "adequate" cleansing of the small intestine
Measured: one year
Secondary outcomes (1)
Diagnostic rate of video capsule endoscopy
Diagnostic rate of video capsule endoscopy
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of Small Bowel PreparationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital
- Responsible party
- Principal investigator, Wei-Fen Xie, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099392
- Sponsor's protocol ID
- CZXH202301
- Status last verified
- Oct 2023
- First submitted
- 16 Jul 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcutaneous Electrical Acustimulation Combined With Polyethylene Glycol-electrolyte on the Quality of Small Bowel Preparation for Capsule Endoscopy
- ClinicalTrials.gov ID
- NCT06099392
- Acronym / sponsor ID
- CZXH202301
- Conditions
- Quality of Small Bowel Preparation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Collaborators
- RenJi Hospital
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 25 Oct 2023 (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.
Transcutaneous elctroacupuncture(TEA) at ST36 can improve gastrointestinal motility. Therefore,the investigators hypothesized that if TEA is applied to the preparation of small bowel capsule endoscopy, the small bowel peristalsis of patients can be regulated by electrical stimulation at (ST36). On the one hand, it can be used in combination with compound polyethylene glycol electrolyte powder, which is conducive to the discharge of small bowel contents and improve the imaging quality. On the other hand, it can improve the diagnostic rate by adjusting the intestinal transit time, And the completion rate of the examination can be improved by accelerating the gastric emptying time of capsule endoscopy.
Therefore, in order to explore the effect of TEA stimulation at ST36 combined with polyethylene glycol powder on preparation for small bowel capsule endoscopy, the investigators designed this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEA group | Experimental | Device: digital stimulators (SNM-FDC01, Ningbo MaidaMedical Device, Inc, Ningbo, China)TEA at ST36 (Zusanli) combined with 2L Polyethylene Glycol Electrolytes Powder for bowel preparation |
| Sham-TEA group | No intervention | –2L Polyethylene Glycol Electrolytes Powder for bowel preparation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Agree to sign an informed consent form; Aged 18 to 75 years old Plan to undergo small bowel capsule endoscopy;
Key exclusion criteria (1 listed)
- Clinical diagnosis of gastrointestinal stricture, bowel obstruction, gastrointestinal fistula, intestinal resection; Clinical diagnosis of dysphagia; Those who require fasting or parenteral nutrition support treatment; Individuals with gastrointestinal motility disorders; Oral administration of gastrointestinal motility drugs within 1 week; Implanting medical electronic devices; Those who are allergic to compound polyethylene glycol electrolyte powder and dimethicone oil and cannot tolerate oral laxatives for intestinal preparation; Skin diseases that affect electrode fixation; Pregnant, preparing to conceive, or breastfeeding patients; Familiar with acupuncture and moxibustion treatment, acupoint selection or meridians; Researchers believe that it is not suitable for participants.
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 |
|---|---|---|
| digital stimulators (SNM-FDC01, Ningbo MaidaMedical Device, Inc, Ningbo, China)TEA at Zusanli(ST 36) 45 min when drinking Polyethylene Glycol Electrolytes Powder | Device | TEA group |
Primary outcome
The rate of "adequate" cleansing of the small intestine
Time frame: one year
The rate of "adequate" cleansing of the small intestine
1 secondary outcome
Diagnostic rate of video capsule endoscopy
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
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.
Questions about this trial
What is this clinical trial studying?
A study testing digital stimulators (SNM-FDC01, Ningbo MaidaMedical Device, Inc, Ningbo, China) in people with Quality of Small Bowel Preparation, run by Shanghai Changzheng Hospital.
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: status not confirmed, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei-Fen Xie, MD. PhD ((86) 21 81886824., weifenxie@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of "adequate" cleansing of the small intestine (time frame: one year). 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 25 Oct 2023.