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OpenTrials
Completed

NCT Number: NCT00583466

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

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.

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Key information

Conditions

Large Polyps in the Gastrointestinal Tract

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Polyps equal or larger than 1 cm

Exclusion criteria

  • Coagulopathy
  • Inability to sign informed consent

Treatment and study plan

Autologous blood injection

Drug

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

normal saline

Drug

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

HPMC

Drug

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

Primary outcomes

  1. Duration of the Submucosal Cushion

    Time frame: Immediately after the procedure, Up to 5 minutes

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 31, 2007
Registry last updated
Sep 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.