Trials Sponsors Conditions Drugs Pricing

Conditions

Esophageal Cancer Gastrostomy Head Neck Cancer

Keywords

esophageal cancerBlue laser imagingpercutaneous endoscopic gastrostomyhead neck cancer

Outcome Measures

Primary Outcomes (1)

Detection rate of a second cancer or precancerous lesions
The detection rates for malignant or premalignant lesions in participants with head neck tumors will be compared when using BLI and white light endoscopy
The time frame is during the PEG insertion (approximately 15min)

Study Arms (2)

Standard White Light Imaging

ACTIVE COMPARATOR

In this group the participants will be examined by white light endoscopy first and secondly with blue laser imaging technique during the same gastroscopy.

Diagnostic Test: blue laser imaging

Blue Light Imaging

EXPERIMENTAL

In this group the participants will be examined by blue laser imaging technique first and secondly with standard white light during the same gastroscopy.

Diagnostic Test: blue laser imaging

Interventions

blue laser imagingDiagnostic test

The intervention is the push on demand activation of blue laser imaging technique during gastroscopy.

Blue Light ImagingStandard White Light Imaging

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

All participants with the need of PEG due to head neck cancers or esophageal carcinoma

You may not qualify if:

Sponsors & Collaborators

Georg Dultz
Otherlead

Study Sites (1)

Klinikum der J. W. Goethe-Universität

Frankfurt am Main, Hesse, 60590, Germany

MeSH Terms

Conditions

Head and Neck NeoplasmsEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

Mireen Friedrich-Rust, Professor
Goethe University
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Masking Details: The participants don't know which arm they were allocated to.
Purpose: DIAGNOSTIC
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Record Keeper

Study Record Dates

First Submitted

December 2, 2018

First Posted

September 28, 2020

Study Start

September 22, 2020

Actual (reported)

Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Standard White Light Imaging

Blue Light Imaging

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Standard White Light Imaging

Blue Light Imaging

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Source record

Locations