TDM-621 clinical trial

Not Applicable

• Conditions: Patients undergoing ESD for neoplasia of the stomach and rectum

• Registration Number: JPRN-UMIN000042009
• Lead Sponsor: 3-D Matrix, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-08-14
• Study Start: 2020-10-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 227

Inclusion Criteria

Not provided

Exclusion Criteria

Subjects who met any of the following items at the time of enrollment were excluded from this trial. (1) Patients with local residual recurrence (2) Patients with ulcer in the target lesion (3) Poorly differentiated adenocarcinoma or undifferentiated cancer gastric cancer patients and rectal cancer patients (4) Patients with inflammatory bowel disease including ulcerative colitis (5) Patients with a history of hypersensitivity to peptide or protein products (6) Patients with Grade 2 or higher of Performance status according to the clinical evaluation criteria of cancer chemotherapy (7) Patients with serious liver disease, renal disease, cardiovascular disease, etc. [Assessment of severity of adverse event grade 3 or more in the Common Terminology Criteria for Adverse Events] (8) Patients with a condition in which reticuloendothelial system activity may be decreased such as disseminated intravascular coagulation (9) Patients who are receiving blood coagulation drugs (coagulation promoter = hemocoagulase, etc.), antifibrinolytic drugs (drugs having antifibrinolytic action = tranexamic acid, aprotinin preparation, etc.). However, regardless of the use of antiplatelet drugs, the drug should be discontinued in accordance with the guideline for gastrointestinal endoscopy for patients taking antithrombotic drugs. (10) Patients who are scheduled to undergo heparin replacement for ESD

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the number of coagulation by hemostatic forceps required to achieve intraprocedural haemostasis in TDM-621 versus control groups.