Intestinal PolypsNCT07290816
Effect of Non-invasive Neuromodulation on the Quality of Intestinal Cleansing
A study testing Intestinal pacing + ST36 acupoint stimulation in people with Intestinal Polyps, run by Shanghai East Hospital at 1 site in China.
Trial summary
To clarify whether non-invasive neuromodulation for assisted bowel preparation can improve the quality of bowel preparation, to explore the possible mechanisms by which TEA improves the quality of bowel preparation, and to assess its safety, as well as subjects' tolerance, compliance and satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Intestinal Polyps
- What is being tested?
- Intestinal pacing + ST36 acupoint stimulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2025to 21 Mar 2028
- 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 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 78 years of age, male or female;
- Intended to undergo diagnostic, screening, or surveillance colonoscopy;
- Signed written informed consent.
Who cannot join
- Severe cardiac, cerebral, pulmonary, or renal complications or a history of acute cardiac infarction within six months;
- High risk factors for bowel preparation such as history of colon surgery, BMI ≥ 28, inflammatory bowel disease, constipation (less than 3 bowel movements in the last week, and with straining to defecate, with hard stools and small amount of stools) or bowel obstruction;
- High suspicion of colorectal cancer by auxiliary examination or early warning signs and symptoms of colorectal cancer: blood in stool, black stool, unexplained anemia, significant weight loss, abdominal mass and positive rectal fingerprinting;
- The presence of surgical incisions or scars in the area where the electrostimulation treatment tablets are pasted, or near the ST36 acupoints on both legs;
- Are participating in other clinical observation trials or have participated in other clinical trials within 30 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai East Hospital
Shanghai
Yanni Hu, +86 13681698574, ceciliahhyy@163.com
About this study
Official title: Effect of Non-invasive Neuromodulation on the Quality of Bowel Cleansing: a Randomized, Controlled, Double-blind Clinical Study
To clarify whether non-invasive neuromodulation for assisted bowel preparation can improve the quality of bowel preparation, to explore the possible mechanisms by which TEA improves the quality of bowel preparation, and to assess its safety, as well as subjects' tolerance, compliance and satisfaction.
- Conditions
- Intestinal Polyps
- Being tested
- Intestinal pacing + ST36 acupoint stimulation, Sham acupoint intestinal pacing + sham ST36 acupoint stimulation
- Keywords
- Bowel Preparation, Noninvasive electrical neuromodulation
- Medical subject headings
- Intestinal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intestinal pacing + ST36 acupoint stimulationOther
The day before the examination began a real stimulation treatment, namely, intestinal pacing (① location: positive pole placed on the navel (the line between the raphe and navel) 1 to 2 cm, the negative pole in the raphe and the navel line at the midpoint of the right 4 to 10 cm; ② parameters: the intestinal frequency: 2.4-3.7 cpm, the first time the frequency of use of 3.0 cpm, treatment of the base wave intensity of 0-15 gears, the first time to use the intestinal treatment intensity of 10 gears) , acupoint stimulation (① location: treatment sheet attached to both legs ST36 acupoints, i.e., four transverse fingers below the eye of the outer knee, 4 transverse fingers next to the tibia; ② parameters: the first use of acupoint intensity 30%, to the patient's self-conscious stimulation points have a slight pinprick sensation, lifting sensation, warm sensation is appropriate).
Sham acupoint intestinal pacing + sham ST36 acupoint stimulationOther
A sham stimulation treatment was started one day before the examination, i.e., intestinal pacing treatment with the electrode pads offset to the lumbar side to stimulate the sham acupoints, and acupoint stimulation with the treatment pads applied to the ST36 acupoints but without turning on the current switch.
| Study group | Role | What they receive |
|---|---|---|
| Trial Group 1 | Experimental | Bowel pacing (specific location and parameters) and ST36 acupoint stimulation (specific location and intensity) were used the day before the examination; 2L of PEG was taken the night before the examination and on the day of the examination, and 30 ml of simethicone was taken orally immediately after all of the 4L of PEG had been taken. Colonoscopy was completed within 2-6 hours after bowel preparation was completed. Receives: Other: Intestinal pacing + ST36 acupoint stimulation |
| Trial Group 2 | Experimental | Sham acupoint bowel pacing and sham ST36 acupoint stimulation were used the day before the examination (electrode pads were offset and current switch was not turned on; 2L of PEG was taken the night before and on the day of the examination, respectively, and 30 ml of simethicone was taken orally immediately after all of the 4L of PEG had been taken. Colonoscopy was completed within 2-6 hours after bowel preparation was completed. Receives: Other: Sham acupoint intestinal pacing + sham ST36 acupoint stimulation |
| Control Group | No intervention | Only conventional treatment was used, with 2 portions of 2000 ml PEG taken with fasting starting at 19:00 pm the night before the examination and required to be taken within 2 hours. On the day of the examination, 2 doses of 2000 ml of PEG were taken orally starting 3-5 hours before the colonoscopy procedure, which was required to be completed within 2 hours, and 30 ml of simethicone was taken orally as soon as the subject had finished taking the laxative, and all bowel preparations had to be completed more than 2 hours and less than 6 hours before the colonoscopy procedure, and if the time limit was exceeded the subject was excluded from the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel Preparedness Score
Using the Boston Bowel Preparation Scale(BBPS)
Measured: Day 2
Secondary outcomes (7)
Polyp detection rate
Measured: Day 2
Adenoma detection rate
Measured: Day 2
Adverse reactions
collected using a questionnaire
Measured: Baseline and Day 2
Complete Blood Count
Measured: Baseline and Day 2
C-Reactive Protein
Measured: Baseline and Day 2
Inflammatory Cytokines(TNF-α，IL-6，IL-10……)
Measured: Baseline and Day 2
Gastrointestinal Hormones (Pancreatic Polypeptide, Motilin, Vasoactive Intestinal Peptide……)
Measured: Baseline and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start31 Dec 2025 (estimated)
- Primary completion21 Mar 2027 (estimated)
- Study completion21 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal PolypsStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290816
- Sponsor's protocol ID
- 2023YS-077 Amendment 1
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- 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 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-invasive Neuromodulation on the Quality of Bowel Cleansing: a Randomized, Controlled, Double-blind Clinical Study
- ClinicalTrials.gov ID
- NCT07290816
- Acronym / sponsor ID
- 2023YS-077 Amendment 1
- Conditions
- Intestinal Polyps
- Keywords
- Bowel Preparation, Noninvasive electrical neuromodulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 21 Mar 2027 (estimated)
- Study completion
- 21 Mar 2028 (estimated)
- First posted
- 18 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.
To clarify whether non-invasive neuromodulation for assisted bowel preparation can improve the quality of bowel preparation, to explore the possible mechanisms by which TEA improves the quality of bowel preparation, and to assess its safety, as well as subjects' tolerance, compliance and satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trial Group 1 | Experimental | Other: Intestinal pacing + ST36 acupoint stimulationBowel pacing (specific location and parameters) and ST36 acupoint stimulation (specific location and intensity) were used the day before the examination; 2L of PEG was taken the night before the examination and on the day of the examination, and 30 ml of simethicone was taken orally immediately after all of the 4L of PEG had been taken. Colonoscopy was completed within 2-6 hours after bowel preparation was completed. |
| Trial Group 2 | Experimental | Other: Sham acupoint intestinal pacing + sham ST36 acupoint stimulationSham acupoint bowel pacing and sham ST36 acupoint stimulation were used the day before the examination (electrode pads were offset and current switch was not turned on; 2L of PEG was taken the night before and on the day of the examination, respectively, and 30 ml of simethicone was taken orally immediately after all of the 4L of PEG had been taken. Colonoscopy was completed within 2-6 hours after bowel preparation was completed. |
| Control Group | No intervention | –Only conventional treatment was used, with 2 portions of 2000 ml PEG taken with fasting starting at 19:00 pm the night before the examination and required to be taken within 2 hours. On the day of the examination, 2 doses of 2000 ml of PEG were taken orally starting 3-5 hours before the colonoscopy procedure, which was required to be completed within 2 hours, and 30 ml of simethicone was taken orally as soon as the subject had finished taking the laxative, and all bowel preparations had to be completed more than 2 hours and less than 6 hours before the colonoscopy procedure, and if the time limit was exceeded the subject was excluded from the study. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 78 years of age, male or female;
- Intended to undergo diagnostic, screening, or surveillance colonoscopy;
- Signed written informed consent.
Key exclusion criteria (5 listed)
- Severe cardiac, cerebral, pulmonary, or renal complications or a history of acute cardiac infarction within six months;
- High risk factors for bowel preparation such as history of colon surgery, BMI ≥ 28, inflammatory bowel disease, constipation (less than 3 bowel movements in the last week, and with straining to defecate, with hard stools and small amount of stools) or bowel obstruction;
- High suspicion of colorectal cancer by auxiliary examination or early warning signs and symptoms of colorectal cancer: blood in stool, black stool, unexplained anemia, significant weight loss, abdominal mass and positive rectal fingerprinting;
- The presence of surgical incisions or scars in the area where the electrostimulation treatment tablets are pasted, or near the ST36 acupoints on both legs;
- Are participating in other clinical observation trials or have participated in other clinical trials within 30 days.
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 |
|---|---|---|
| Intestinal pacing + ST36 acupoint stimulationThe day before the examination began a real stimulation treatment, namely, intestinal pacing (① location: positive pole placed on the navel (the line between the raphe and navel) 1 to 2 cm, the negative pole in the raphe and the navel line at the midpoint of the right 4 to 10 cm; ② parameters: the intestinal frequency: 2.4-3.7 cpm, the first time the frequency of use of 3.0 cpm, treatment of the base wave intensity of 0-15 gears, the first time to use the intestinal treatment intensity of 10 gears) , acupoint stimulation (① location: treatment sheet attached to both legs ST36 acupoints, i.e., four transverse fingers below the eye of the outer knee, 4 transverse fingers next to the tibia; ② parameters: the first use of acupoint intensity 30%, to the patient's self-conscious stimulation points have a slight pinprick sensation, lifting sensation, warm sensation is appropriate). | Other | Trial Group 1 |
| Sham acupoint intestinal pacing + sham ST36 acupoint stimulationA sham stimulation treatment was started one day before the examination, i.e., intestinal pacing treatment with the electrode pads offset to the lumbar side to stimulate the sham acupoints, and acupoint stimulation with the treatment pads applied to the ST36 acupoints but without turning on the current switch. | Other | Trial Group 2 |
Primary outcome
Bowel Preparedness Score
Time frame: Day 2
Using the Boston Bowel Preparation Scale(BBPS)
7 secondary outcomes
Polyp detection rate
Time frame: Day 2
Adenoma detection rate
Time frame: Day 2
Adverse reactions
Time frame: Baseline and Day 2
Complete Blood Count
Time frame: Baseline and Day 2
C-Reactive Protein
Time frame: Baseline and Day 2
Inflammatory Cytokines(TNF-α，IL-6，IL-10……)
Time frame: Baseline and Day 2
Gastrointestinal Hormones (Pancreatic Polypeptide, Motilin, Vasoactive Intestinal Peptide……)
Time frame: Baseline and Day 2
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 18 Dec 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intestinal pacing + ST36 acupoint stimulation in people with Intestinal Polyps, run by Shanghai East Hospital 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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 18 Dec 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?
Contact Lan Zhong (+86 13162099450, lanzhong@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel Preparedness Score (time frame: Day 2). 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 18 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.