Phase 2
N=18
Evaluation of Blood as a Submucosal Cushion During Endoscopic Polypectomy and Mucosal Resection
Large Polyps in the Gastrointestinal Tract
Bottom Line
View on ClinicalTrials.gov: NCT00583466 ↗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
| Outcome | Result | p-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
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.