Stomach DiseasesPhase 2NCT02846155
Gastric Preparation of Magnetic-controlled Capsule Endoscopy
A Phase 2 study testing clear water, simethicone and simethicone combined with pronase in people with Stomach Diseases, run by Changhai Hospital at 2 sites in China.
Trial summary
By using three different Gastric Preparation of Magnetic-controlled Capsule Endoscopy, the investigators hope to find out the optimal gastric preparation plan. Read more about this study
- Who is it for?
- Ages 16 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stomach Diseases
- What is being tested?
- clear water, simethicone and simethicone combined with pronase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- May 2016to Dec 2016
- Phase
- Phase 2
- 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 16 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult patients aged 16-75 years, who were scheduled to undergo a Magnetic-controlled Capsule Endoscopy, were eligible for this study.
Who cannot join
- Dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or postabdominal radiation;
- Congestive heart failure, renal insufficiency, under therapeutic anticoagulation, in poor general condition (American Society of Anesthesiologists class III/IV), claustrophobia, metallic parts, a pacemaker or other implanted electromedical devices, artificial heart valves;
- Pregnancy or suspected pregnancy;
- Exclusion criteria for standard magnetic resonance imaging (MRI) examination such as the presence of surgical metallic devices, even though its low magnetic field would technically not interfere with such devices;
- Currently participating in another clinical study.
Trial locations and contacts
2 sites in 1 country.
Zhuan Liao contact
China2 sites, 2 recruiting
- Recruiting
Changhai Hospital
Shanghai
Zhuan Liao, liaozhuan@smmu.edu.cn
Shu Guang Zhu
- Recruiting
Changhai Hospital
Shanghai
Zhuan Liao, liaozhuan@smmu.edu.cn
Shu-Guang Zhu
About this study
Official title: Gastric Preparation of Magnetic-controlled Capsule Endoscopy: A Prospective, Single Blinded and Randomized Controlled Trial
By using three different Gastric Preparation of Magnetic-controlled Capsule Endoscopy, the investigators hope to find out the optimal gastric preparation plan.
Read the detailed description
It is a prospective, single-blind, randomized controlled trial. Patients who were conducted by Magnetic-controlled Capsule Endoscopy at Changhai Hospital will be randomly allocated into three different Gastric Preparation group before the procedure. It include clear water group which patient only drink 1000ml clear water before checking; simethicone group which patient drink 950ml clear water and 15ml simethicone before checking; simethicone combined with pronase group which patient drink 900ml lear water and 15ml simethicone and 20，000iu pronase before checking. The result were got from a relevant professional physician's blinded independent image-reading.
- Conditions
- Stomach Diseases
- Being tested
- clear water, simethicone, simethicone combined with pronase
- Keywords
- preparation, capsule endoscopy
- Medical subject headings
- Stomach Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clear waterOther
the patients just drink common clear water before Magnetic-controlled Capsule Endoscopy examination
simethiconeDrug
the patients drink clear water and simethicone (Espumisan; Berlin-Chemie, Germany, containing 40 mg simethicone in 1 mL emulsion) before Magnetic-controlled Capsule Endoscopy examination
simethicone combined with pronaseDrug
the patients drink simethicone (Espumisan; Berlin-Chemie, Germany, containing 40 mg simethicone in 1 mL emulsion)，pronase granules（Deyou；Beijing Tide Pharmaceutical Co，China,containing 20,000iu pronase），and clear water before Magnetic-controlled Capsule Endoscopy examination
| Study group | Role | What they receive |
|---|---|---|
| clear water group | Placebo comparator | the patients only drink 1000ml clear water before checking Receives: Other: clear water |
| simethicone group | Experimental | the patients drink 950ml clear water and 15ml simethicone before checking Receives: Drug: simethicone |
| simethicone combined with pronase group | Experimental | the patients drink 900ml clear water and 15ml simethicone and 20，000iu pronase before checking Receives: Drug: simethicone combined with pronase |
What is being measured
The primary outcome is the main question the study is designed to answer.
the level of gastric cleansing
Two investigators who did not know which kind of gastric preparation of the patient scored the level of gastric cleansing 0f 120 participants according to a four-point grading scale: poor, fair, good, and excellent，which was pointed 3,2,1，and 0.The investigators should evaluate the gastric cleansing of six anatomical landmarks (cardia, fundus, body, angulus, antrum and pylorus).A poor level of cleansing indicated the mucosa was obscured largely by a lot of air bubbles and grume,fair indicated that a portion of the mucosa was obscured by air bubbles and grume that was enough to prevent a reliable visualization of polyps, good indicated that a small amount of air bubbles and grume，and excellent indicated that the fluid was clear and the image was either free or had only small bits of air bubbles and grume.
Measured: 4 month
Secondary outcomes (6)
Transit time
include gastric transit time，smal bowel transit time
Measured: 4 month
Diagnostic yield of Magnetic-controlled Capsule Endoscopy
The gastric focal lesion was defined as any of the positive findings including polyp, ulcers, submucosal tumor (SMT) and others (i.e. xanthoma, diverticulum, etc.). Erosion, gastritis and gastric atrophy were defined as negative findings, because they are diffuse lesions which can be easily diagnosed by Magnetic-controlled Capsule Endoscopy.
Measured: 4 month
Tolerability of participants
The endoscopist scored the tolerability of participants according to a three-point grading scale: poor, fair, and excellent，which was pointed 2,1，and 0.A poor tolerability of participants indicated patients with perforated severe abdominal pain,nausea, vomiting，etc.fair indicated patients with perforated little abdominal pain,nausea, vomiting.and excellent indicated that patients with no obvious discomfort.
Measured: 4 month
the visibility of gastric
Two investigators scored the level of gastric visibility 0f 120 participants according to a four-point grading scale: poor, fair, good, and excellent，which was pointed 3,2,1,and 0.The investigators should evaluate the visibility of gastric of six anatomical landmarks (cardia, fundus, body, angulus, antrum and pylorus).A poor level of cleansing indicated the less than 50% of mucosa could be seen,fair indicated that 50%-75% of the mucosa could be seen, good indicated that more than 75% of the mucosa could be seen，and excellent indicated the whole mucosa could be seen.
Measured: 4 month
the time of gastric examination
the time indicated since the first gastric mucosal image was observed to the endoscopist completed the whole gastric examination。
Measured: 4 month
the added amount of water of the whole process during gastric examination
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach DiseasesStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 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
- NCT02846155
- Sponsor's protocol ID
- 20160410A
- Status last verified
- Jul 2016
- First submitted
- 21 Jul 2016
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Preparation of Magnetic-controlled Capsule Endoscopy: A Prospective, Single Blinded and Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02846155
- Acronym / sponsor ID
- 20160410A
- Conditions
- Stomach Diseases
- Keywords
- preparation, capsule endoscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 27 Jul 2016 (estimated)
- 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 using three different Gastric Preparation of Magnetic-controlled Capsule Endoscopy, the investigators hope to find out the optimal gastric preparation plan.
Detailed description
It is a prospective, single-blind, randomized controlled trial. Patients who were conducted by Magnetic-controlled Capsule Endoscopy at Changhai Hospital will be randomly allocated into three different Gastric Preparation group before the procedure. It include clear water group which patient only drink 1000ml clear water before checking; simethicone group which patient drink 950ml clear water and 15ml simethicone before checking; simethicone combined with pronase group which patient drink 900ml lear water and 15ml simethicone and 20，000iu pronase before checking. The result were got from a relevant professional physician's blinded independent image-reading.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| clear water group | Placebo comparator | Other: clear waterthe patients only drink 1000ml clear water before checking |
| simethicone group | Experimental | Drug: simethiconethe patients drink 950ml clear water and 15ml simethicone before checking |
| simethicone combined with pronase group | Experimental | Drug: simethicone combined with pronasethe patients drink 900ml clear water and 15ml simethicone and 20，000iu pronase before checking |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients aged 16-75 years, who were scheduled to undergo a Magnetic-controlled Capsule Endoscopy, were eligible for this study.
Key exclusion criteria (5 listed)
- Dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or postabdominal radiation;
- Congestive heart failure, renal insufficiency, under therapeutic anticoagulation, in poor general condition (American Society of Anesthesiologists class III/IV), claustrophobia, metallic parts, a pacemaker or other implanted electromedical devices, artificial heart valves;
- Pregnancy or suspected pregnancy;
- Exclusion criteria for standard magnetic resonance imaging (MRI) examination such as the presence of surgical metallic devices, even though its low magnetic field would technically not interfere with such devices;
- Currently participating in another clinical study.
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 |
|---|---|---|
| clear waterthe patients just drink common clear water before Magnetic-controlled Capsule Endoscopy examination | Other | clear water group |
| simethiconethe patients drink clear water and simethicone (Espumisan; Berlin-Chemie, Germany, containing 40 mg simethicone in 1 mL emulsion) before Magnetic-controlled Capsule Endoscopy examination | Drug | simethicone group |
| simethicone combined with pronasethe patients drink simethicone (Espumisan; Berlin-Chemie, Germany, containing 40 mg simethicone in 1 mL emulsion)，pronase granules（Deyou；Beijing Tide Pharmaceutical Co，China,containing 20,000iu pronase），and clear water before Magnetic-controlled Capsule Endoscopy examination | Drug | simethicone combined with pronase group |
Primary outcome
the level of gastric cleansing
Time frame: 4 month
Two investigators who did not know which kind of gastric preparation of the patient scored the level of gastric cleansing 0f 120 participants according to a four-point grading scale: poor, fair, good, and excellent，which was pointed 3,2,1，and 0.The investigators should evaluate the gastric cleansing of six anatomical landmarks (cardia, fundus, body, angulus, antrum and pylorus).A poor level of cleansing indicated the mucosa was obscured largely by a lot of air bubbles and grume,fair indicated that a portion of the mucosa was obscured by air bubbles and grume that was enough to prevent a reliable visualization of polyps, good indicated that a small amount of air bubbles and grume，and excellent indicated that the fluid was clear and the image was either free or had only small bits of air bubbles and grume.
6 secondary outcomes
Transit time
Time frame: 4 month
Diagnostic yield of Magnetic-controlled Capsule Endoscopy
Time frame: 4 month
Tolerability of participants
Time frame: 4 month
the visibility of gastric
Time frame: 4 month
the time of gastric examination
Time frame: 4 month
the added amount of water of the whole process during gastric examination
Time frame: 4 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Stomach Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Peptic Ulcer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 2
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
Overweight or Obesity
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.
Zhuan Liao contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing clear water, simethicone and simethicone combined with pronase in people with Stomach Diseases, run by Changhai Hospital at 2 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 1 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: status not confirmed, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhuan Liao (liaozhuan@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the level of gastric cleansing (time frame: 4 month). 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 27 Jul 2016.