MedTrace Logo

Purastat® vs Standard Therapy for Haemostasis During Endoscopic Submucosal Dissection

NCT02833558 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2018-06-26

No results posted yet for this study

Summary

Endoscopic submucosal dissection (ESD) is an endoscopic resection technique used to treat superficial neoplasia in the gastrointestinal tract. Bleeding is a commonly encountered problem during submucosal dissection and is usually managed with electrocautery. However, this does carry a risk of deep thermal injury and perforation.

PuraStat® is a novel extracellular scaffold matrix of amino acids that forms a transparent adherent barrier when applied to a bleeding point.

The aim of this trial is to study the use of PuraStat® in reducing the need for thermal haemostasis during ESD.

Conditions

  • Gastrointestinal Haemorrhage

Interventions

DEVICE

PuraStat®

PuraStat® gel is applied through a safe catheter delivery system (via endoscope) over the bleeding point

PROCEDURE

Electrocautery

Electrocautery (coagulation current) to stop bleeding during ESD

Sponsors & Collaborators

  • Portsmouth Hospitals NHS Trust

    lead OTHER_GOV

Principal Investigators

  • Pradeep Bhandari, MBBS, MD · Portsmouth Hospitals NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-04
Primary Completion
2018-04-12
Completion
2018-05-18

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02833558 on ClinicalTrials.gov