Phase I trial for feasibility of EGD with steady pressure automatically controlled endoscopy (SPACE).

Phase I trial for feasibility of EGD with steady pressure automatically controlled endoscopy (SPACE). - Phase I trial for SPACE-EGD.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007107

Enrollment

Registered

2012-01-23

Start date

2012-01-01

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

Patients who undergo screening EGD.

Interventions

Screening EGD with steady pressure automatically controlled endoscopy (SPACE)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who undergo screening EGD 2) Without past history of gastrectomy or esophagectomy. 3) The age is more than 20 and less than 80. 4) PS (ECOG) is 0 or 1. 5) Not to show significant abnormality by respiratory function test. (FEV1.0 is more than 70%, %VC is more than 80%) 6) Written informed consent has been obtained.

Exclusion criteria

Exclusion criteria: 1) Patients of Chronic Obstructive Pulmonary Disease (COPD) 2) In cases of suspected overt gastrointestinal bleeding or perforation. 3) To be judged inapropriate to participate this trial by contact person.

Design outcomes

Primary

Measure	Time frame
Completion rate of EGD	—

Secondary

Measure	Time frame
1) Rate of adverse event (based on NCI-CTCAE ver. 4.0) 2) The changes of vital signs during EGD 3) The findings of abdominal Xp immediately after EGD 4) Procedure time 5) Patients' Subjective score 6) Endoscopists' Subjective score	—

Countries

Japan

Contacts

Public ContactKiyokazu Nakajima

Osaka University Graduate School of Medicine Department of Gastroenterological Surgery

knakajima@surg1.med.osaka-u.ac.jp

Outcome results

None listed

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