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Evaluation of Blood as a Submucosal Cushion During Endoscopic Polypectomy and Mucosal Resection

NCT00583466 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-09-13

Study results available
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Summary

For removal of large flat lesions of the gastro-intestinal tract injection of a solution under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal tract wall. Various solutions are currently used, but some of them are easy to inject but quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive and not always available. The investigators performed previously animal experiments which demonstrated that blood is easy to inject and creates a protective cushion which lasts longer than other fluids which are currently used for protective cushion creation.

Conditions

  • Large Polyps in the Gastrointestinal Tract

Interventions

DRUG

Autologous blood injection

Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion

DRUG

Normal saline

Normal saline will be injected under the lesion to create submucosal cushion

DRUG

HPMC

Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion

Sponsors & Collaborators

Principal Investigators

  • Sergey V. Kantsevoy, M.D., Ph.D. · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00583466 on ClinicalTrials.gov