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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05054933
Other study ID # Ultrasound CE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 26, 2021
Est. completion date July 30, 2022

Study information

Verified date September 2021
Source Changhai Hospital
Contact Zhuan Liao, Professor
Phone (81)02131161024
Email zhuanleo@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date July 30, 2022
Est. primary completion date May 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Participants aged 18 years or older. 2. Both inpatients and outpatients. 3. Healthy volunteers or patients with suspected esophageal disease 4. Able to provide informed consent. Exclusion Criteria: 1. known or suspected complex history of gastrointestinal obstruction, stenosis or fistula. 2. dysphagia. 3. known or suspected possibility of active bleeding of digestive tract. 4. Pregnancy or suspected pregnancy.. 5. Patients who have participated in or are participating in other clinical trials within three months. 6. Life-threatening conditions. 7. other circumstances that doctors consider inappropriate for the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ultrasound capsule endoscopy
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.

Locations

Country Name City State
China Changhai Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Qiu 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. — View Citation

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. Review. — View Citation

Ughi 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 month
Secondary Diagnostic accuracy The diagnostic accordance rate, sensitivity and specificity of lesions detected by ultrasound capsule endoscopy compared with conventional endoscopic ultrasound examination. 1 month
Secondary 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 1 month
Secondary Safety of ultrasound capsule endoscopy examination The presence of any adverse events during ultrasound capsule endoscopy examination procedure will be recorded. 1 month
Secondary Examination time of esophagus Record the time taken to finish examination of esophagus under ultrasound capsule endoscopy. 1 month
Secondary 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. 1 month
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