Trials / Completed
CompletedNCT04800991
NuGa (Nutrition for Gastric Cancer Patients)
A Pilot Study to Evaluate the Feasibility and Efficacy of Digital Health Technology for Postoperative Care With Gastrectomy-Treated Patients in Gastric Cancer
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Seoul National University Hospital · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this pilot study is to evaluate the feasibility and efficacy of Rhexium Onco Nutrition, HDT-202 for post-operative care in patients who have undergone gastrectomy.
Detailed description
1. A total of 4 visits will be performed. 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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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 |
Timeline
- Start date
- 2021-03-17
- Primary completion
- 2021-10-08
- Completion
- 2021-10-08
- First posted
- 2021-03-16
- Last updated
- 2021-10-20
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04800991. Inclusion in this directory is not an endorsement.