Tokyo, Aug. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062698) titled 'A Study on the Safety of Colon Capsule Endoscopy for Post-Transplant Colitis' on Aug. 26.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - National Cancer Center
Condition:
Condition - Hematologic Malignancies, Graft Versus Host Disease, Cytomegalovirus Colitis
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - This study focuses on patients suspected gut-GVHD or CMV colitis after hematopoietic stem cell transplantation and aims to evaluate the clinical safety and feasibility of using a colon capsule endoscopy.
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - Colon Capsule Endoscopy
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - We'll make anyone who meets all of the following criteria a study participant.
1) Patients who are between 18 and 75 years old at the time of consent
2) Patients who have undergone hematopoietic stem cell transplantation
3) Patients suspected of having post-transplant enteritis
4) Patients who have given written consent
Key exclusion criteria - Exclude from the study anyone who meets any of the following criteria:
1) Patients suspected of having an intestinal blockage
2) Patients with kidney problems (eGFR below 30)
3) Patients who have trouble swallowing or have esophageal narrowing
4) Patients for whom a colon capsule endoscopy isn't covered by insurance
5) Anyone else the principal investigator thinks isn't suitable
Target Size - 15
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 26 Day
Date of IRB - 2026 Year 08 Month 26 Day
Anticipated trial start date - 2026 Year 09 Month 08 Day
Last follow-up date - 2027 Year 09 Month 08 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071791
Disclaimer: Curated by HT Syndication.