臨床研究等提出・公開システム

Date of registration	June. 25, 2020
Last modified on	Nov. 21, 2023
Trial ID	jRCT1080225247

Scientific Title	A Randomized, Controlled, Pivotal Study of SI-449 Adhesion Barrier in Patients with Temporary Ileostomy
Public Title	A pivotal study of SI-449 adhesion barrier

Contact for Scientific Queries	Name	Sagawa Kenji
	Contact Name for Scientific Queries	SEIKAGAKU CORPORATION
	Address	6-1, Marunouchi 1, Chiyoda-ku, Tokyo 100-0005, Japan.
	Phone Number	+81-3-5220-8593
	E-mail Address	reply@seikagaku.co.jp

Contact for Public Queries	Name	Ando Kumi
	Contact Name for Public Queries	SEIKAGAKU CORPORATION
	Address	6-1, Marunouchi 1, Chiyoda-ku, Tokyo 100-0005, Japan.
	Phone Number	+81-3-5220-8593
	E-mail Address	reply@seikagaku.co.jp

Recruitment Status	completed

Date of First Enrolment		July. 15, 2020
Target Sample Size		130
Study Type		Interventional
Study Design	Study Design	multicenter prospective randomized open blinded-endpoint parallel-group controlled trial
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Rectal cancer patients who plan to undergo laparotomy rectal resection with temporary ileostomy and second-stage ileostomy closure.
	Exclusion Criteria	Patients with history of surgery in the abdominal or pelvic cavity. Patients with having active infection in the abdominal or pelvic cavity. Patients with having active or previous history of peritonitis. Patients with history of hypersensitivity to the investigational device. Patients with a serious hepatic or a serious renal disorder Patients who participated in another clinical study of any drug or medical device within 16 weeks prior to the day of informed consent
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Rectal cancer
Intervention(s)		investigational material(s) Generic name etc : SI-449 INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : A sufficient amount of SI-449 will be applied around the organ under the midline incision. As a general rule, 2 units of product (2 g) will be used. control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy Adhesions forming under midline incision
Secondary Outcome		safety efficacy other efficacy safety operability Adhesion severity Extent of adhesions The incidence of adverse events

Primary Sponsor	SEIKAGAKU CORPORATION
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Review Board of Human Rights and Ethics for Clinical Studies Institutional Review Board
Address of IRB	13-2 Ichibancho, Chiyoda-ku, Tokyo, Japan
Phone Number of IRB	+81-3-5213-0028
E-mail Address of IRB	secretariat@hurecs.org
Status of IRB Review	approved
Date of Approval by IRB	May. 26, 2020

Secondary ID No.	JapicCTI-205343
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
4	Nov. 21, 2023	(this page)	Changes
3	Oct. 12, 2023	Detail	Changes
2	April. 17, 2023	Detail	Changes
1	June. 26, 2020	Detail

List of change history