Trial of cleansing drink to improve visualisation during gastroscopy

Phase 1

• Conditions: Early gastrointestinal lesions in the upper gastrointestinal tract.Our study is not looking at the direct treatment of any particular condition, but the early detecton of lesions. When performing upper gastrointestinal endoscopy it is a common problem to find views obscured by mucous and foam. We therefore intend to use n-acetyl cysteine and Simeticone as a mucolytic agent, potentially improving views of the mucosa and therefore enabling early detection of small lesions.; MedDRA version: 14.1Level: PTClassification code 10014809Term: Endoscopy gastrointestinalSystem Organ Class: 10022891 - Investigations; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2013-001097-24-GB
• Lead Sponsor: Portsmouth Hospitals NHS trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-29
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

Patients undergoing upper gastrointestinal endoscopy at Portsmouth Hospitals NHS Trust
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 63
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 63

Exclusion Criteria

•Cases where there is significant oesophagitis preventing accurate assessment
•Emergency cases (eg gastrointestinal bleeding)
•Patients who would already receive NAC/Simethicone pre-endoscopy as part of their standard care
•Patients with a known stricture or stenosis (narrowing)
•Pregnant or breastfeeding women
•Patients with a known upper gastrointestinal malignancy
•Patients with a previous CVA resulting in pharyngeal weakness or paralysis
•Patients with bulbar or pseudobulbar palsy
•Patients with a history of previous oesophageal or gastric surgery
•Patients who are currently in another clinical trial
•Patients with a known allergy to NAC or Simeticone
•Patients without the capacity to give informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified