Magnetic Anastomosis Device Relief of Malignant Gastric Outlet Obstruction

NCT00487552 | Terminated Results

• 2 other identifiers: 06-014900000
• Study Type: interventional
• Target: 18
• Locations: 3 countries
• Sites: 4

Brief Summary

The purpose of this study is to determine if the Cook Magnetic Anastomosis Device can be used to safely and successfully create a patent gastrojejunal anastomosis in subjects requiring treatment of gastric outlet obstruction caused by malignancy.

Conditions

Gastric Outlet Obstruction

Keywords

endoscopy; esophagogastroduodenoscopy; gastric outlet obstruction; gastro-jejunostomy; gastric malignancy; duodenal stent; Malignant Gastric Outlet Obstruction

Outcome Measures

Primary Outcomes (1)

• Success Rate Associated With the Creation of a Gastro-jejunal Anastomosis Using the Cook Magnetic Anastomosis Device With Trans-anastomotic Deployment of a Gastro-jejunal or Duodenal Stent

  Success is defined as placement of the gastric and jejunal magnets, creation of the anastomosis, and deployment of the gastro-jejunal stent.

  Approximately 8-10 days

Study Arms (1)

1

EXPERIMENTAL

palliative treatment of gastric outlet obstruction

Device: Cook Magnetic Anastomosis Device (MAD) with Stent

Interventions

Cook Magnetic Anastomosis Device (MAD) with Stent DEVICE

Gastro-jejunal anastomosis

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with unresectable malignancy with, or at risk of developing gastric outlet obstruction with GOOSS ≤ 2
• Karnofsky Performance Score ≥ 60

You may not qualify if:

• Patient is unable to understand and execute informed consent
• Age below 18 years
• Patients with any prior gastrointestinal surgery that significantly alters gastrojejunal anatomy
• Implanted cardiac pacemaker, defibrillator or ventricular assist device
• Requirement for chronic anticoagulation, or with uncorrectable coagulopathy
• Patients receiving chronic steroids or other drugs that may impair wound healing or formation of an intact anastomosis
• Simultaneously participating in another investigational drug or device
• Patients with suspicion of, or documented multiple small bowel strictures

Sponsors & Collaborators

• Cook Group Incorporated: lead
• MED Institute, Incorporated: collaborator
• Cook Endoscopy: collaborator

Study Sites (4)

Hospital de Erasme

Brussels, Belgium

Location

Instituto di Clinical Chirurgica

Rome, Italy

Location

Amsterdam Academic Medical Center

Amsterdam, Netherlands

Location

University Medical Center Utrecht

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Gastric Outlet Obstruction; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Limitations and Caveats

Enrollment was stopped in Feb 2009, due to the death of a patient after distal stent migration.

Results Point of Contact

• Title: Scott Snyder, Ph.D., Manager, Biostatistics and Data Management, Senior Statistician
• Organization: MED Institute, Inc.

ssnyder@medinst.com

765-463-7537

Study Officials

• Paul Fockens, MD, PhD

  Amsterdam Academic Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2007
• First Posted: June 18, 2007
• Study Start: January 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: April 1, 2011
• Last Updated: August 23, 2017
• Results First Posted: July 27, 2012

Record last verified: 2017-07

Locations

BE (1); IT (1); NL (2)