Tactile sensor for laparoscopic surgery

Phase 1

• Conditions: gastric cancer, gastric GIST; gastric cancer

• Registration Number: JPRN-jRCTs042180117
• Lead Sponsor: Fujiwara Michitaka

Brief Summary

This system is effective for detecting the lesion invisible from the serosal surface, and it is considered that there are no major problems in its practical application.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-19
• Study Completion: 2020-03-31
• Results First Posted: 2021-01-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1) Histologically proven gastric adenocarcinoma.
2) cStage IA(T1N0) or IB(T1N1, T2[MP]N0) or IIA(T3[SS]N0).
3) PS(ECOG) of 0 or 1.
4) No history of upper abdominal surgery.

Exclusion Criteria

1) Infectious disease with systemic therapy indicated.
2) Body temperature of 38 or more degrees Celsius.
3) Women during pregnancy or breast-feeding.
4) Severe mental disease.
5) Continuous systemic steroid therapy.
6) Unstable angina pectoris, or history of myocardial infarction within six months.
7) Uncontrollable hypertension.
8) Uncontrollable diabetes millutus.
9) Severe respiratory disease requiring continuous oxygen therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine whether lesion or marker clip position can be detected.

Secondary Outcome Measures

Name	Time	Method
- Investigate whether the display attached to the operator interferes with the operation.<br>- Investigate whether the display attached to the operator interferes with other surgical instruments