CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Autologous blood injection +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00583466
NCT00583466Phase 2Completed

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

Johns Hopkins University·interventional·Posted Dec 31, 2007·Updated Sep 13, 2017

In Brief

A Phase 2 clinical trial evaluating Autologous blood injection, Normal saline, and 1 other intervention for Large Polyps in the Gastrointestinal Tract. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 31, 2007
Enrollment StartMay 1, 2007
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.5 years ago

Interventions

Autologous blood injectiondrug

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

Normal salinedrug

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

HPMCdrug

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