Phase 0 study of three-dimensional endoscopic optical coherence tomography (u-VOIS)

Phase 0 study of three-dimensional endoscopic optical coherence tomography (u-VOIS) - u-VOIS phase 0

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002866

Enrollment

Registered

2010-01-25

Start date

2010-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer, Gastric Cancer, Colorectal Cancer

Interventions

Endoscopic examinations of mucosal membrane using three-dimensional optical coherence tomography probe.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven esophageal cancer, gastric cancer and colon cancer. 2) Macroscopic morphological tumor type is as follows. 2)-1 Esophageal cancer:0-II or 0-III 2)-2 Gastric cancer: II or III 2)-3 Colon cancer: IIa, IIb, IIc, IIa+IIc, IIc+IIa 3)Endoscopic findings are as follows. 3)-1 Esophageal cancer: size of tumor is <= 3cm, depth of invasion is clinical T1a and located within the thoracic esophagus. 3)-2 Gastric cancer: size of tumor <=4cm with ulcer (-) and well differentiated adenocarcinoma, <=3cm with ulcer (+) and well differentiated adenocarcinoma, or <=2cm with poorly differentiated adenocartinoma. And depth of invasion is clinical M without pylorus or cardia invasion. 3)-3 Colon cancer: size of tumor <= 3cm, depth of invasion is clinical M or SM slight invasion. 4) no scar on the planned EMR area. 5) Clinical N0/M0 6) One-piece resection is possible with EMR 7) Aged 20 to 80 years old. 8) PS (ECOG) of 0 or1. 9) without synchronous or metachronous cancer 10) No prior treatment of surgery, chemotherapy or radiation for cancer. 11) Sufficient organ function. 12) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Impossible to discontinue anticoagulant or antiplatelet medication. 2) Women during pregnancy or breast-feeding. 3) Psychosis. 4) Systemic steroids medication. 5) Active bacterial or fungal infection. 6) History of myocardial infarction or unstable angina pectoris within three months. 7) Uncontrollable hypertension. 8) Uncontrollable diabetes mellitus or administration of insulin. 9) History of allergy to latex.

Design outcomes

Primary

Measure	Time frame
Discrimination ability of mucosal membrane structure. Discrimination ability of cancer tissue.	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026