Health AdultsNCT07877506
Sodium Bicarbonate Solution Enhances Lens Cleanliness in Magnetically Controlled Capsule Endoscopy
A study testing Sodium Bicarbonate Solution in people with Health Adults, run by Changhai Hospital.
Trial summary
Magnetically controlled capsule endoscopy (MCE) is a noninvasive alternative to conventional gastroscopy with comparable diagnostic accuracy. However, mucus adherence to the capsule lens during examination can severely impair visualization, and MCE lacks an irrigation mechanism for lens cleaning. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Adults
- What is being tested?
- Sodium Bicarbonate Solution
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Oct 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Provision of written informed consent
- Lens cleanliness score of 2 or lower (i.e., score 2 or 1) on a 4-point scale during MCE examination before intervention
Who cannot join
- Dysphagia
- Suspected or confirmed esophageal stenosis or obstruction
- Overt gastrointestinal bleeding
- Poor general condition
- Pregnancy or suspected pregnancy
- Known allergy to sodium bicarbonate
- Current participation in another clinical study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Sodium Bicarbonate Solution Enhances Lens Cleanliness of Magnetically Controlled Capsule Endoscopy: a Prospective, Self-controlled Study
Magnetically controlled capsule endoscopy (MCE) is a noninvasive alternative to conventional gastroscopy with comparable diagnostic accuracy. However, mucus adherence to the capsule lens during examination can severely impair visualization, and MCE lacks an irrigation mechanism for lens cleaning. Current guidelines provide no intra-procedural recommendations for managing lens soiling. This study aimed to evaluate the efficacy of sodium bicarbonate solution in improving MCE lens cleanliness during gastric examination.
- Conditions
- Health Adults
- Being tested
- Sodium Bicarbonate Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Bicarbonate SolutionProcedure or surgery
The capsule lens is aimed at the cardia. Use 30ml of 1% sodium bicarbonate solution (food-grade baking soda) to clean the capsule lens.
| Study group | Role | What they receive |
|---|---|---|
| Sodium Bicarbonate Solution | Experimental | Not described Receives: Procedure: Sodium Bicarbonate Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of study participants with a baseline lens cleanliness score ≤2 who achieved good or excellent lens cleanliness (cleanliness score ≥3) at the cardia after cleansing with sodium bicarbonate solution, defined as the cleansing success rate.
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health AdultsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877506
- Sponsor's protocol ID
- SBS-MCE-LensClean
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 16 Oct 2026
- 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Bicarbonate Solution Enhances Lens Cleanliness of Magnetically Controlled Capsule Endoscopy: a Prospective, Self-controlled Study
- ClinicalTrials.gov ID
- NCT07877506
- Acronym / sponsor ID
- SBS-MCE-LensClean
- Conditions
- Health Adults
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 16 Oct 2026 (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.
Magnetically controlled capsule endoscopy (MCE) is a noninvasive alternative to conventional gastroscopy with comparable diagnostic accuracy. However, mucus adherence to the capsule lens during examination can severely impair visualization, and MCE lacks an irrigation mechanism for lens cleaning. Current guidelines provide no intra-procedural recommendations for managing lens soiling. This study aimed to evaluate the efficacy of sodium bicarbonate solution in improving MCE lens cleanliness during gastric examination.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sodium Bicarbonate Solution | Experimental | Procedure: Sodium Bicarbonate Solution |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Provision of written informed consent
- Lens cleanliness score of 2 or lower (i.e., score 2 or 1) on a 4-point scale during MCE examination before intervention
Key exclusion criteria (7 listed)
- Dysphagia
- Suspected or confirmed esophageal stenosis or obstruction
- Overt gastrointestinal bleeding
- Poor general condition
- Pregnancy or suspected pregnancy
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 |
|---|---|---|
| Sodium Bicarbonate SolutionThe capsule lens is aimed at the cardia. Use 30ml of 1% sodium bicarbonate solution (food-grade baking soda) to clean the capsule lens. | Procedure or surgery | Sodium Bicarbonate Solution |
Primary outcome
The proportion of study participants with a baseline lens cleanliness score ≤2 who achieved good or excellent lens cleanliness (cleanliness score ≥3) at the cardia after cleansing with sodium bicarbonate solution, defined as the cleansing success rate.
Time frame: From enrollment to the end of treatment at 2 weeks
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 16 Oct 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Bicarbonate Solution in people with Health Adults, run by Changhai 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 3 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: opening soon, as of the sponsor's last update on 16 Oct 2026. 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?
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 Zhuan Liao (8613061921980, zhuanleo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of study participants with a baseline lens cleanliness score ≤2 who achieved good or excellent lens cleanliness (cleanliness score ≥3) at the cardia after cleansing with sodium bicarbonate solution, defined as the cleansing success rate. (time frame: From enrollment to the end of treatment at 2 weeks). 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 16 Oct 2026.