Esophageal DiseasesNCT05054933
Ultrasound Capsule Endoscopy for Esophagus Examination
A study testing ultrasound capsule endoscopy in people with Esophageal Diseases, run by Changhai Hospital at 1 site in China.
Trial summary
The aim of this pilot study is to assess the feasibility and safety of the clinical application of ultrasound capsule endoscopy in esophageal examination compared with conventional endoscopic ultrasound examination. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Esophageal Diseases
- What is being tested?
- ultrasound capsule endoscopy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 26 Sep 2021to 30 Jul 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants aged 18 years or older.
- Both inpatients and outpatients.
- Healthy volunteers or patients with suspected esophageal disease
- Able to provide informed consent.
Who cannot join
- known or suspected complex history of gastrointestinal obstruction, stenosis or fistula.
- dysphagia.
- known or suspected possibility of active bleeding of digestive tract.
- Pregnancy or suspected pregnancy..
- Patients who have participated in or are participating in other clinical trials within three months.
- Life-threatening conditions.
- other circumstances that doctors consider inappropriate for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Zhuan Liao, +86-21-31161004, liaozhuan@smmu.edu.cn
About this study
Official title: Feasibility and Safety of Ultrasound Capsule Endoscopy for Esophagus Examination：a Pilot Study
The aim of this pilot study is to assess the feasibility and safety of the clinical application of ultrasound capsule endoscopy in esophageal examination compared with conventional endoscopic ultrasound examination.
Read the detailed description
Wireless capsule endoscopy has opened a new era by enabling remote diagnostic assessment of the gastrointestinal tract in a painless procedure. However, most commercially available devices only utilise optical imaging to examine the GI wall surface. Using this sensing modality, pathology within the GI wall cannot be detected. Micro-ultrasound (mUS) using high-frequency (>20 MHz) ultrasound can provide a means of transmural or cross-sectional image of the GI tract. Depth of imaging is approximately 10 mm with a resolution of between 40-120 μm that is sufficient to differentiate between subsurface histologic layers of the various regions of the GI tract. Ultrasound capsule endoscopy (USCE) uses a capsule equipped with mUS transducers that are capable of imaging below the GI wall surface, offering thereby a complementary sensing technique to optical imaging capsule endoscopy. In this work, a USCE device integrated with a 40 MHz ultrasonic transducer was developed to capture a full 360˚ image of the lumen. Previous animal studies of two anaesthetised Landrace pigs have demonstrated the effectiveness of the device. The reconstructed images demonstrate clear layer differentiation of the lumen wall. The tissue thicknesses measured from the B-scan images show good agreement with ex vivo images from the literature. The aim of this pilot study is to assess the feasibility and safety of the clinical application of ultrasound capsule endoscopy in esophageal examination compared with conventional endoscopic ultrasound examination.
- Conditions
- Esophageal Diseases
- Being tested
- ultrasound capsule endoscopy
- Keywords
- capsule endoscopy; ultrasound
- Medical subject headings
- Esophageal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound capsule endoscopyOther
Healthy volunteers or patients with suspected esophageal disease will be enrolled to take ultrasound capsule endoscopy examination followed by conventional endoscopic ultrasound examination within 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ultrasound capsule endoscopy examination | Other | Healthy volunteers or patients with suspected esophageal disease will be enrolled to take ultrasound capsule endoscopy examination followed by conventional endoscopic ultrasound examination within 2 weeks. Receives: Other: ultrasound capsule endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of esophageal examination
Assess the success rate of the clinical application of ultrasound capsule endoscopy in esophageal examination, including observe the mucosa completely and obtain ultrasound cross-sectional images in specific parts.
Measured: 1 month
Secondary outcomes (5)
Diagnostic accuracy
The diagnostic accordance rate, sensitivity and specificity of lesions detected by ultrasound capsule endoscopy compared with conventional endoscopic ultrasound examination.
Measured: 1 month
Clear layer differentiation of the esophageal wall structure
Assess the success rate of clear layer differentiation of the esophageal wall structure by ultrasound capsule endoscopy examination
Measured: 1 month
Safety of ultrasound capsule endoscopy examination
The presence of any adverse events during ultrasound capsule endoscopy examination procedure will be recorded.
Measured: 1 month
Examination time of esophagus
Record the time taken to finish examination of esophagus under ultrasound capsule endoscopy.
Measured: 1 month
Discomfort scores associated with ultrasound capsule endoscopy examination
Assess the discomfort score caused by the string, swallowing the ultrasound capsule, pulling the capsule up or down, and pulling the capsule out. A visual analogue scale ranging from 0 (easy with no nausea) to 10 (very difficult or with sever nausea) was used to evaluate the degree of difficulty of the discomfort score caused by the string.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start26 Sep 2021
- Primary completion30 May 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Esophageal 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
- Investigators
- Zhuan Liao, Professor, Principal investigator, Changhai Hospital,Shanghai,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054933
- Sponsor's protocol ID
- Ultrasound CE
- Status last verified
- Sep 2021
- First submitted
- 19 Sep 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thosani N, Singh H, Kapadia A, Ochi N, Lee JH, Ajani J, Swisher SG, Hofstetter WL, Guha S, Bhutani MS. Diagnostic accuracy of EUS in differentiating mucosal versus submucosal invasion of superficial esophageal cancers: a systematic review and meta-analysis. Gastrointest Endosc. 2012 Feb;75(2):242-53. doi: 10.1016/j.gie.2011.09.016. Epub 2011 Nov 23.
PubMed 22115605Qiu Y, Huang Y, Zhang Z, Cox BF, Liu R, Hong J, Mu P, Lay HS, Cummins G, Desmulliez MPY, Clutton E, Zheng H, Qiu W, Cochran S. Ultrasound Capsule Endoscopy With a Mechanically Scanning Micro-ultrasound: A Porcine Study. Ultrasound Med Biol. 2020 Mar;46(3):796-804. doi: 10.1016/j.ultrasmedbio.2019.12.003. Epub 2020 Jan 3.
PubMed 31902446Ughi GJ, Gora MJ, Swager AF, Soomro A, Grant C, Tiernan A, Rosenberg M, Sauk JS, Nishioka NS, Tearney GJ. Automated segmentation and characterization of esophageal wall in vivo by tethered capsule optical coherence tomography endomicroscopy. Biomed Opt Express. 2016 Jan 8;7(2):409-19. doi: 10.1364/BOE.7.000409. eCollection 2016 Feb 1.
PubMed 26977350Qiu XO, Jiang X, Chen YZ, Xia JS, Pan J, Wang L, Liao Z, Li ZS. New US capsule endoscopy for superficial and submucosal imaging of the esophagus: the first-in-human study. Gastrointest Endosc. 2023 Oct;98(4):642-652. doi: 10.1016/j.gie.2023.06.015. Epub 2023 Jun 24.
PubMed 37356634
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Ultrasound Capsule Endoscopy for Esophagus Examination：a Pilot Study
- ClinicalTrials.gov ID
- NCT05054933
- Acronym / sponsor ID
- Ultrasound CE
- Conditions
- Esophageal Diseases
- Keywords
- capsule endoscopy; ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 26 Sep 2021 (actual)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 23 Sep 2021 (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.
The aim of this pilot study is to assess the feasibility and safety of the clinical application of ultrasound capsule endoscopy in esophageal examination compared with conventional endoscopic ultrasound examination.
Detailed description
Wireless capsule endoscopy has opened a new era by enabling remote diagnostic assessment of the gastrointestinal tract in a painless procedure. However, most commercially available devices only utilise optical imaging to examine the GI wall surface. Using this sensing modality, pathology within the GI wall cannot be detected. Micro-ultrasound (mUS) using high-frequency (>20 MHz) ultrasound can provide a means of transmural or cross-sectional image of the GI tract. Depth of imaging is approximately 10 mm with a resolution of between 40-120 μm that is sufficient to differentiate between subsurface histologic layers of the various regions of the GI tract. Ultrasound capsule endoscopy (USCE) uses a capsule equipped with mUS transducers that are capable of imaging below the GI wall surface, offering thereby a complementary sensing technique to optical imaging capsule endoscopy. In this work, a USCE device integrated with a 40 MHz ultrasonic transducer was developed to capture a full 360˚ image of the lumen. Previous animal studies of two anaesthetised Landrace pigs have demonstrated the effectiveness of the device. The reconstructed images demonstrate clear layer differentiation of the lumen wall. The tissue thicknesses measured from the B-scan images show good agreement with ex vivo images from the literature. The aim of this pilot study is to assess the feasibility and safety of the clinical application of ultrasound capsule endoscopy in esophageal examination compared with conventional endoscopic ultrasound examination.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasound capsule endoscopy examination | Other | Other: ultrasound capsule endoscopyHealthy volunteers or patients with suspected esophageal disease will be enrolled to take ultrasound capsule endoscopy examination followed by conventional endoscopic ultrasound examination within 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants aged 18 years or older.
- Both inpatients and outpatients.
- Healthy volunteers or patients with suspected esophageal disease
- Able to provide informed consent.
Key exclusion criteria (7 listed)
- known or suspected complex history of gastrointestinal obstruction, stenosis or fistula.
- dysphagia.
- known or suspected possibility of active bleeding of digestive tract.
- Pregnancy or suspected pregnancy..
- Patients who have participated in or are participating in other clinical trials within three months.
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 |
|---|---|---|
| ultrasound capsule endoscopyHealthy volunteers or patients with suspected esophageal disease will be enrolled to take ultrasound capsule endoscopy examination followed by conventional endoscopic ultrasound examination within 2 weeks. | Other | ultrasound capsule endoscopy examination |
Primary outcome
Success rate of esophageal examination
Time frame: 1 month
Assess the success rate of the clinical application of ultrasound capsule endoscopy in esophageal examination, including observe the mucosa completely and obtain ultrasound cross-sectional images in specific parts.
5 secondary outcomes
Diagnostic accuracy
Time frame: 1 month
Clear layer differentiation of the esophageal wall structure
Time frame: 1 month
Safety of ultrasound capsule endoscopy examination
Time frame: 1 month
Examination time of esophagus
Time frame: 1 month
Discomfort scores associated with ultrasound capsule endoscopy examination
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Background: PubMed 22115605Thosani N, Singh H, Kapadia A, Ochi N, Lee JH, Ajani J, Swisher SG, Hofstetter WL, Guha S, Bhutani MS. Diagnostic accuracy of EUS in differentiating mucosal versus submucosal invasion of superficial esophageal cancers: a systematic review and meta-analysis. Gastrointest Endosc. 2012 Feb;75(2):242-53. doi: 10.1016/j.gie.2011.09.016. Epub 2011 Nov 23.
- Background: PubMed 31902446Qiu Y, Huang Y, Zhang Z, Cox BF, Liu R, Hong J, Mu P, Lay HS, Cummins G, Desmulliez MPY, Clutton E, Zheng H, Qiu W, Cochran S. Ultrasound Capsule Endoscopy With a Mechanically Scanning Micro-ultrasound: A Porcine Study. Ultrasound Med Biol. 2020 Mar;46(3):796-804. doi: 10.1016/j.ultrasmedbio.2019.12.003. Epub 2020 Jan 3.
- Background: PubMed 26977350Ughi GJ, Gora MJ, Swager AF, Soomro A, Grant C, Tiernan A, Rosenberg M, Sauk JS, Nishioka NS, Tearney GJ. Automated segmentation and characterization of esophageal wall in vivo by tethered capsule optical coherence tomography endomicroscopy. Biomed Opt Express. 2016 Jan 8;7(2):409-19. doi: 10.1364/BOE.7.000409. eCollection 2016 Feb 1.
- Derived from this study: PubMed 37356634Qiu XO, Jiang X, Chen YZ, Xia JS, Pan J, Wang L, Liao Z, Li ZS. New US capsule endoscopy for superficial and submucosal imaging of the esophagus: the first-in-human study. Gastrointest Endosc. 2023 Oct;98(4):642-652. doi: 10.1016/j.gie.2023.06.015. Epub 2023 Jun 24.
- 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. This study is not recruiting at the moment.
Zhuan Liao, Professor principal investigator
Changhai Hospital,Shanghai,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound capsule endoscopy in people with Esophageal Diseases, run by Changhai 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 4 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: status not confirmed, as of the sponsor's last update on 1 Oct 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhuan Liao, Professor ((81)02131161024, zhuanleo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of esophageal examination (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05054933, which also lists 4 linked publications.
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 1 Oct 2021.