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

September 11, 2017 updated by: Johns Hopkins University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 decided to use blood drawn from the patient for injection under the lesion. 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. Blood can also have local hemostatic action preventing from bleeding during polypectomy.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Polyps equal or larger than 1 cm

Exclusion Criteria:

  • Coagulopathy
  • Inability to sign informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1 Normal saline arm
Polypectomy with normal saline injected for submucosal cushion creation
Drug: Normal saline
Normal saline will be injected under the lesion to create submucosal cushion
Active Comparator: 2 HPMC arm
Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion
Drug: HPMC
Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion
Experimental: 3 Blood arm
Polypectomy after injection of autologous blood
Drug: Autologous blood injection
Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of the Submucosal Cushion
Time Frame: Immediately after the procedure, Up to 5 minutes
Immediately after the procedure, Up to 5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Sergey V. Kantsevoy, M.D., Ph.D., Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 20, 2007

First Posted (Estimate)

December 31, 2007

Study Record Updates

Last Update Posted (Actual)

September 13, 2017

Last Update Submitted That Met QC Criteria

September 11, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NA_00008376

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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