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

Safety and Feasibility Study of a Novel Submucosal Injection Material for Endoscopic Resection of Gastrointestinal Tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032220175
Enrollment
11
Registered
2022-07-02
Start date
2022-08-04
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

Stomach Neoplasms, Colorectal Neoplasms Stomach Neoplasms, Colorectal Neoplasms

Interventions

When performing endoscopic submucosal dissection, PuraLift is injected into the submucosal layer.
Endoscopic Mucosal Resection

Sponsors

Kuribayashi Shiko
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Description and frequency of adverse events and diseases

Secondary

MeasureTime frame
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

Contacts

Public ContactKasuga Kengo

Gunma University Graduate School of Medicine

kngo.ksga0127@gmail.com+81-27-220-8137

Outcome results

None listed

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