Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2021-03-17
2021-10-08
Brief Summary
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Detailed Description
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2. At the screening visit,subject's written informed consent, assessing the inclusion/exclusion criteria and assigning enrollment numbers to eligible subjects, demographic information taking, medical history/medication history taking, vital signs measuring, physical examination, height and body weight measuring, instructing how to install/use the investigational device, and administering quality of life questionnaires.
3. During the treatment period, a total of 3 visits will be performed. To evaluate feasibility and efficacy, the following procedures will be carried out: vital signs measuring, physical examination, nutrition assessment/consultation, evaluation of feasibility for 'subjects', evaluation of feasibility for 'investigators', and adverse events (AEs)/concomitant medications checking and collecting.
4. During the treatment period, telephone monitoring is conducted depending on the compliance of subjects.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Rhexium Onco Nutrition(HDT-202)
"subject mobile application" and "Investigator web portal" with no invasive action on the human body
Rhexium Onco Nutrition
The research devices in this study are classified into "subject mobile application" and "investigator web portal" with no invasive action on the human body
Interventions
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Rhexium Onco Nutrition
The research devices in this study are classified into "subject mobile application" and "investigator web portal" with no invasive action on the human body
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age of ≥19 years old
3. Patient who has undergone therapeutic gastrectomy after a diagnosis of gastric cancer
4. Able to eat food orally after gastrectomy
5. Patient who possesses an Android OS based mobile device and is capable of using the investigational device.
Exclusion Criteria
2. Ongoing or planned enteral tube feeding or total parenteral nutrition
3. Other clinically significant medical or psychiatric findings based on which the individual is considered by the investigator to be ineligible
4. Individual who possesses a mobile device on which the application is unable to be installed and/or run normally for technical reasons
5. Individual who, in the opinion of the investigator, has difficulty understanding how to use the investigational device or is unlikely to comply with other study procedures
19 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Han-Kwang Yang
Professor
Principal Investigators
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Han-Kwang Yang, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Department of Surgery, Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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Park JH, Lee HJ, Kim J, Cho YS, Lee S, Park S, Choe H, Song E, Kim Y, Kong SH, Park DJ, Nam BH, Yang HK. Development and Feasibility Assessment of Mobile Application-Based Digital Therapeutics for Postoperative Supportive Care in Gastric Cancer Patients Following Gastrectomy. J Gastric Cancer. 2024 Oct;24(4):420-435. doi: 10.5230/jgc.2024.24.e37.
Other Identifiers
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HDT-202_F01
Identifier Type: -
Identifier Source: org_study_id