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Preoperative Marking of the Oral Resection Margin in Esophageal Cancer With a Surgical Fiducial Marker - First Experiences

NCT05069766 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-02-23

No results posted yet for this study

Summary

This study aims to evaluate if BioXmark™, a surgical marker, may efficiently and safely be used to preoperatively mark the proximal and distal resection line 5 cm proximal and distal to the tumor margin of gastroesophageal-junction adenocarcinoma (GEJ AC).

Furthermore, to determine if placing the resection margin according to the resection margin defined by BioXmark™ is superior to the current standard of a proximal resection line estimation by the individual surgeon based on the intraoperative findings.

Conditions

  • Esophagus Cancer, Adenocarcinoma

Interventions

OTHER

BioXmark™

During a scheduled outpatient gastroscopy, the tumor margins will be endoscopically marked by BioXmark™. BioXmark™ will be implanted at the most proximal margin of the tumor and 5 cm proximally of the tumor border.

Sponsors & Collaborators

  • Nanovi

    collaborator UNKNOWN

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Michael P Achiam, MD, DMSCi · Rigshospitalet, Denmark

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-06-01
Completion
2022-06-01

Countries

  • Denmark

Study Locations

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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 NCT05069766 on ClinicalTrials.gov