NCT01185483

Brief Summary

Endoscopic submucosal dissection (ESD) is a relatively new modality for the treatment of superficial gastrointestinal neoplasia and especially in the diagnosis and treatment of submucosal tumors. ESD has become a minimal invasive alternative to surgery but requires a high degree of endoscopic skills to be performed safely, it is time consuming, and less safe than endoscopic mucosa resection. New endoscopic instruments have been developed to increase the efficacy and safety of ESD, and a combined endoscopic instrument (HybridKnife) has been developed and evaluated with promising results in animal studies. This HybridKnife allows high-pressure water-jet (submucosal) dissection, as well as cutting and coagulation and makes ESD possible without changing instrument. The purpose of this study is to evaluate the feasibility and safety of using HybridKnife for ESD in humans.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

September 6, 2010

Status Verified

August 1, 2010

Enrollment Period

1 year

First QC Date

August 17, 2010

Last Update Submit

September 3, 2010

Conditions

Endoscopy, Digestive SystemEsophageal NeoplasmsStomach Neoplasms

Keywords

Endoscopic submucosal dissectionSubmucosal tumorMinimal invasiveGastroscopy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to the Endoscopic Section at the Department of Surgery, Odense University Hospital, with a mucosal or submucosal tumor in the esophagus or stomach.

You may qualify if:

  • Submucosal tumor (\< 4 cm)
  • Mucosal tumor (T1) in patients unsuitable for surgery

You may not qualify if:

  • Endoscopic ultrasound (EUS) or CT signs of metastasis
  • Insufficient access to tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5250, Denmark

RECRUITING

MeSH Terms

Conditions

Esophageal NeoplasmsStomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Michael H. Larsen, M.D.

CONTACT

0045 29694631mhl@dadlnet.dk

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 20, 2010

Study Start

November 1, 2009

Primary Completion

November 1, 2010

Study Completion

February 1, 2011

Last Updated

September 6, 2010

Record last verified: 2010-08

Locations

DK(1)