Safety and Feasibility Study of PuraLift in Endoscopic Resection of Gastrointestinal Tumors

JRCT ID: jRCT1032220175

Registered date:02/07/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Stomach Neoplasms, Colorectal Neoplasms
• Date of first enrollment: 04/08/2022
• Target sample size: 11
• Study type: Interventional
• Intervention(s): When performing endoscopic submucosal dissection, PuraLift is injected into the submucosal layer.

Outcome(s)

• Primary Outcome: Description and frequency of adverse events and diseases
• Secondary Outcome: Ease of injection of PuraLift, ease of mucous membrane incision, ease of submcosal dissection, maintenance of mucous membrane elevation, intraoperative incidentals, time required for excision, amount of PuraLift used, postoperative bleeding

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who are able to obtain written consent from the individual
2) Age 20 years or older at the time of consent
3) Patients with intramucosal neoplastic lesions in the stomach or colon
4) Patients scheduled for endoscopic submucosal dissection as treatment for neoplastic lesions

Exclude criteria

1) Patients with residual or recurrent lesions
2) Patients with ulcers in the lesion
3) Patients with multiple lesions for the target procedure
(4) Patients with a history of hypersensitivity to any of the components of this product
5) Patients with bleeding tendency
6) Pregnant women or women who wish to become pregnant during the study period and nursing mothers
(7) Patients for whom a follow-up visit to the hospital seems impossible
(8) Patients with serious hepatic, renal, cardiovascular, or other diseases
(9) Other patients deemed inappropriate for this study by the principal investigator or subinvestigator.

Related Information

• Primary Sponsor: Kuribayashi Shiko