Usefulness of EZ FIX? Cushion for endoscopic submucosal dissection of gastric epithelial neoplasms

Usefulness of EZ FIX? Cushion for endoscopic submucosal dissection of gastric epithelial neoplasms: A prospective randomized trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000373

Enrollment

100

Registered

2012-03-02

Start date

2012-04-02

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Medical Device : EZ FIX? Cushion is a patient positioning device. We use this device for purpose of controlling patient's movement during ESD.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a. gastric adenoma (no limitation in size) b. EGC (expanded criteria) /c no LN involvement or metastasis by CT ? Differentiated type - mucosal cancer /s ulcer finding irrespective of tumor size - mucosal cancer /c ulcer finding = 3cm - minute (<500µm from mm) sm invasive cancer = 3cm ? Undifferentiated type - mucosal cancer /s ulcer finding = 2cm

Exclusion criteria

Exclusion criteria: a. current use of aspirin, antiplatelet, anticoagulant, NSAIDs, steroid b. abnormal coagulation profile c. Women either pregnant or at risk of pregnancy d. Lactating women e. ASA(American Society of Anesthesiologists)III or IV or severe comorbidity

Design outcomes

Secondary

Measure	Time frame
Overall satisfaction with sedation of medical staffs; Overall satisfaction with procedure of medical staffs;Overall satisfaction with sedation and procedure of patient;Procedure related myalgia of patient;antagonistic feelign for EZ FIX? Cushion of patient	—

Primary

Measure	Time frame
Satisfaction with EZ FIX? Cushion of medical staffs	—

Countries

Korea, Republic of

Contacts

Public ContactBong Eun Lee

Pusan National University Hospital

Outcome results