L-Gastrectomy With the Intelligent Navigation 4K UHD 3D Endoscopic Imaging System
Safety and Efficacy of a Novel Intelligent Navigation 4K UHD 3D Endoscopic Imaging System in Laparoscopic Gastrectomy
1 other identifier
interventional
67
0 countries
N/A
Brief Summary
This study aims to evaluate the safety, efficacy, and feasibility of the Intelligent Navigation 4K UHD 3D Endoscopic Imaging System in patients with gastric cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2020
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2020
CompletedFirst Posted
Study publicly available on registry
August 25, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedAugust 25, 2020
August 1, 2020
2 years
August 19, 2020
August 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The success rate of laparoscopic gastric surgery
Rate of successfully performed laparoscopic gastrectomy
24 months
Secondary Outcomes (1)
Lymph node dissection rate
24 months
Study Arms (1)
laparoscopic gastrectomy with Intelligent Navigation 4K UHD 3D
EXPERIMENTALInterventions
Laparoscopic gastrectomy with Intelligent Navigation 4K UHD 3D Endoscopic Imaging System
Eligibility Criteria
You may qualify if:
- Diagnosed with gastric cancer require surgery;
- Without a history of abdominal surgery;
- BMI ≤ 30 kg/m2;
- Preoperative ECOG score is 0\~1 and ASA score is I\~III;
- Having signed the Medical Informed Consent.
You may not qualify if:
- Patients with metastasis or invasion of surrounding tissues;
- Undergoing emergency operation (perforation, hemorrhage, obstruction);
- Patients with serious medical co-morbidity (heart, lung, liver and kidney diseases) and could not tolerate laparoscopic surgery;
- With poor incorrigible physical condition before surgery;
- The patient who underwent gastrojejunostomy or jejunostomy;
- The patient who refuses to accept standardized postoperative systemic therapy according to the guidelines.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Minhua Zheng
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2020
First Posted
August 25, 2020
Study Start
October 1, 2020
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
August 25, 2020
Record last verified: 2020-08