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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005434
Receipt No. R000006449
Scientific Title Phase I trial for safety and feasibility of steady pressure automatically controlled endoscopy (SPACE).
Date of disclosure of the study information 2011/04/14
Last modified on 2013/09/10

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Basic information
Public title Phase I trial for safety and feasibility of steady pressure automatically controlled endoscopy (SPACE).
Acronym Phase I trial for SPACE.
Scientific Title Phase I trial for safety and feasibility of steady pressure automatically controlled endoscopy (SPACE).
Scientific Title:Acronym Phase I trial for SPACE.
Region
Japan

Condition
Condition Superficial esophageal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and feasibility of steady pressure automatically controlled endoscopy (SPACE) for patients with esophageal epithelial neoplasm
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of adverse event (based on NCI-CTCAE ver. 4.0)
Key secondary outcomes 1) Completion rate of ESD
2) The changes of pCO2 before and after ESD
3) The changes of vital signs during ESD
4) En bloc margin negative rate of ESD
5) Procedure duration
6) Patients' subjective symptom
7) Dosage amount of sedative during ESD

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Esophageal ESD with steady pressure automatically controlled endoscopy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) To be diagnosed as SCC or High grade intraepithelial neoplasia by endoscopic forceps biopsy.
2) The invasion depth is diagnosed endoscopically as T1a-EP or T1a-LPM.
3) The lesion occupies less than 2/3 of the circumference of esophagus.
4) Without past history of esophagectomy.
5) Not to be involved cervical esophagus or esophago-gastro junction.
6) The age is more than 20 and less than 80.
7) PS (ECOG) is 0 or 1.
8) Not to show significant abnormality by respiratory function test.
9) Main organ function is maintained by blood sampling.
10) Written informed consent has been obtained.
Key exclusion criteria 1) To be affected infectious disease which need systemic treatment.
2) With body temperature higher than 38C
3) To have bleeding tendency.
4) Pregnancy or possibility of pregnancy or breast-feeding woman
5) Psychiatric disease
6) To be treated systemic steroid therapy
7) Unstable angina
8) Uncontrolled hypertension
9) Uncontrolled DM
10) Unable to interrupt anticoaglant for ESD
11) To be judged inapropriate to participate this trial by contact person
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyokazu Nakajima
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address 2-2, E-2, Yamadaoka, Suita, Osaka 565-0871, Japan
TEL 06-6876-0550
Email knakajima@surg1.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyokazu Nakajima
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address 2-2, E-2, Yamadaoka, Suita, Osaka 565-0871, Japan
TEL 06-6876-0550
Homepage URL
Email knakajima@surg1.med.osaka-u.ac.jp

Sponsor
Institute Japan SPACE study group
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大阪大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The commonly observed adverse events were dysphagia, laryngeal pain, and chest pain, but no adverse event was of grade 3 or more. Mild PaCO2 elevation after ESD was addressed; however, there was no symptom associated with hypercapnia. The procedure was completed under SPACE alone in 8 out of 10 patients. Post-procedural bowel distension was minimal according to the patient visual analogue scale and radiographic grading.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 04 Month 13 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2012 Year 06 Month 16 Day
Date of closure to data entry
2013 Year 09 Month 10 Day
Date trial data considered complete
2013 Year 09 Month 10 Day
Date analysis concluded
2013 Year 09 Month 10 Day

Other
Other related information

Management information
Registered date
2011 Year 04 Month 13 Day
Last modified on
2013 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006449

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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