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Phase 2 N=18 Randomized Treatment

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

Large Polyps in the Gastrointestinal Tract

Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Duration of the Submucosal Cushion

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Autologous blood injection (Drug); Normal saline (Drug); HPMC (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Johns Hopkins University
Primary completion
May 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Duration of the Submucosal Cushion

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.

Eligibility Criteria

Inclusion Criteria

  • Polyps equal or larger than 1 cm

Exclusion Criteria

  • Coagulopathy
  • Inability to sign informed consent
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00583466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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