Condition category
Cancer
Date applied
12/06/2013
Date assigned
14/06/2013
Last edited
24/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Dr Laurence Lovat

ORCID ID

Contact details

University College London Hospitals NHS Trust
235 Euston Square
London
NW1 2BU
United Kingdom
-
l.lovat@uclh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol Version 3.1

Study information

Scientific title

Radiofrequency ablation of Barrett's columnar lined oesophagus and squamous dysplasia: multicentre trial with long term follow up using a central database

Acronym

Study hypothesis

The aim of this prospective, multi-centre patient registry study is to provide a tool for participating physician investigators to collect outcome data related to the use of the HALO Ablation Systems. We hypothesise that RFA is safe and effective in treating patients with dysplasia arising in Barrett's oesophagus and will maintain a durable response.

Ethics approval

National Research Ethics Service (NRES), ref. 08/H0714/27

Study design

Prospective multi-centre patient registry

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Oesophageal Cancer/ Barrett's Oesophagus

Intervention

HALO radiofrequency ablation (HALO RFA)
The study collects the outcomes of patients undergoing the intervention which is RFA. The study collects not just demographic data on patients eligible for RFA treatment but also the effectiveness of the treatment in curing them of early oesophageal neoplasia. The study collates the number of procedures required to get to this point but also examines the reasons why we fail in a minority of patients so we can try understand these patients to help improve our practice and streamline our approach to them.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Endoscopic clearance rate for Barrett's esophagus. Percentage of patients with no endoscopically visible Barrett's oesophagus at 1 year follow-up
2. Histological clearance rate for intestinal metaplasia. Percentage of patients with no histological evidence of intestinal metaplasia at 1 year follow-up
3. Histological clearance rate for columnar dysplasia. Percentage of patients with baseline dysplasia who have no histological evidence of dysplasia at 1 year follow-up
4. Sub-squamous intestinal metaplasia. Percentage of patients at 1 year follow-up with sub-squamous intestinal metaplasia, with or without dysplasia, that is covered completely by an intact layer of squamous epithelium with no communication with the surface

Secondary outcome measures

Ability of aneuploidy and other molecular changes to predict success or failure of this therapy.

Overall trial start date

31/03/2008

Overall trial end date

31/03/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients will be recruited from those referred for ablative management of Barrett's oesopahgus or squamous dysplasia with HALO RFA
2. Patients must have no contraindications to endoscopy
3. Males and non-pregnant females over the age of 21 years. Female patients who are pre-menopausal must practice a medically acceptable form of contraception.
4. Patients must sign an informed consent form

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1000

Participant exclusion criteria

1. Presence of invasive carcinoma of the oesophagus
2. Patients in whom endoscopy is contraindicated
3. Patients with oesophageal varices
4. Previous radiotherapy
5. Patients who have undergone Hellers myotomy
6. Pregnant females
7. People under the age of 21 years

Recruitment start date

31/03/2008

Recruitment end date

31/03/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London Hospitals NHS Trust
London
NW1 2BU
United Kingdom

Sponsor information

Organisation

Joint UCLH/UCL Biomedical Research Unit (UK)

Sponsor details

c/o Mr Philip Diamond
1st Floor Maple House
149 Tottenham Court Road
London
W1P 9LL
London
W1P 9LL
United Kingdom
-
philip.diamond@uclh.nhs.uk

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

BAARX Medical Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25539672

Publication citations

Additional files

Editorial Notes