Ultrasound Capsule Endoscopy for Esophagus Examination

NCT05054933 | Unknown

• 1 other identifier: Ultrasound CE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Diseases

Keywords

capsule endoscopy; ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Diagnostic accuracy

  1 month

• Clear layer differentiation of the esophageal wall structure

  1 month

• Safety of ultrasound capsule endoscopy examination

  1 month

• Examination time of esophagus

  1 month

• Discomfort scores associated with ultrasound capsule endoscopy examination

  1 month

Study Arms (1)

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.

Other: ultrasound capsule endoscopy

Interventions

ultrasound capsule endoscopy 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.

ultrasound capsule endoscopy examination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged 18 years or older.
• Both inpatients and outpatients.
• Healthy volunteers or patients with suspected esophageal disease
• Able to provide informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 22115605 BACKGROUND

• 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.

  PMID: 31902446 BACKGROUND

• 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.

  PMID: 26977350 BACKGROUND

• Qiu 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.

  PMID: 37356634 DERIVED

MeSH Terms

Conditions

Esophageal Diseases

Interventions

High-Energy Shock Waves; Endoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Zhuan Liao, Professor

  Changhai Hospital,Shanghai,China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhuan Liao, Professor

CONTACT

(81)02131161024; zhuanleo@126.com

Xi Jiang, PhD

CONTACT

81-13127952352; jiangxi_stella@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 19, 2021
• First Posted: September 23, 2021
• Study Start: September 26, 2021
• Primary Completion: May 30, 2022
• Study Completion: July 30, 2022
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)