Location of Lesions Responsible for Blood Loss in the Gastrointestinal (GI) Tract

NCT04840433 | Unknown DMC

• 1 other identifier: 2020.370
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to identify the prevalence, nature and location of lesions in the GI tract that may contribute to iron deficiency anaemia and compare diagnostic yied of the upper GI magnetic controlled capsule endoscopy with conventional gastroscopy.

Conditions

Iron Deficiency Anemia

Keywords

magnetically assisted capsule endoscopy

Outcome Measures

Primary Outcomes (1)

• Prevalence and nature of lesions in the upper GI tract, small bowel and colon that cause IDA

  Prevalence and nature of lesions in the upper GI tract, small bowel and colon that cause IDA

  1.5 years

Secondary Outcomes (2)

• Comparison of diagnostic performance between MACE and gastroscopy in the upper GI tract in detecting lesions that cause IDA

  1.5 years

• Comparison of patient acceptability of MACE and gastroscopy by patient questionnaire

  1.5 years

Study Arms (1)

MACE

EXPERIMENTAL

Patients will receive MACE for IDA.

Device: MACE

Interventions

MACE DEVICE

Using magnetically assisted capsule endoscopy to examine oesophagus and stomach

MACE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged 18 years and over and up to but not exceeding 80 years
• Patients presenting with IDA whom require gastroscopy and colonoscopy as per national guidelines (1)

You may not qualify if:

• Patients who have contraindications to gastroscopy or colonoscopy
• Patients under the age of 18 years
• Patients over the age of 80 years
• Active vomiting
• Patients with a permanent pacemaker, implantable cardioverter-defibrillator or REVEAL device
• Patients with any electronic/magnetic/mechanically controlled devices e.g. sacral nerve stimulators, bladder stimulators
• Patients with dysphagia, odynophagia or known swallowing disorder
• Patients with known Zenker's diverticulum
• Patients with suspected bowel obstruction or bowel perforation
• Patients with prior bowel obstruction
• Patients with gastroparesis or known gastric outlet obstruction
• Patients with known Crohn's disease
• Patients who are taking daily non-steroidal anti-inflammatory drugs (excluding prophylactic doses of aspirin) for more than six months
• Patients who have received abdominopelvic radiotherapy treatment
• Patients with a history of GI tract surgery (Billroth I, Billroth II, Oesophagectomy, gastrectomy or bariatric procedure)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

RECRUITING

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Felix Sia

CONTACT

26370428; felixsia@cuhk.edu.hk

Thomas Lam

CONTACT

26370428; thomaslam@cuhk.edu.hk

Study Design

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

Model Details: All subjects will be invited to have MACE before their endoscopy and colonoscopy.

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 12, 2021
• Study Start: April 12, 2021
• Primary Completion: August 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 13, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)