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Prospective Study of a New Endolumenal Device Used During Endoscopic Polypectomy in the Colon

NCT04657601 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2020-12-08

No results posted yet for this study

Summary

This prospective observational study will evaluate the performance of the DiLumen C2 Endolumenal Interventional Platform and its instruments. Up to 100 subjects will be enrolled at up to 5 clinical sites. Patient data will be collected before the procedure, during the procedure, and up until the patient is discharged from the hospital.

Conditions

  • Polyps of Colon

Interventions

DEVICE

DiLumen C2 Endolumenal Interventional Platform

Dual balloon accessory to an endoscope and related instruments

Sponsors & Collaborators

  • Lumendi, LLC

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2021-12-31
Completion
2022-03-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04657601 on ClinicalTrials.gov