Magnetic Anastomosis Device Relief of Malignant Gastric Outlet Obstruction (MAD)

This study has been terminated.

(Failure to achieve one of the primary endpoints.)

Sponsor:

Collaborators:

MED Institute, Incorporated

Cook Endoscopy

Information provided by (Responsible Party):

Cook

ClinicalTrials.gov Identifier:

NCT00487552

First received: June 15, 2007

Last updated: June 21, 2012

Last verified: June 2012

History of Changes

Results First Received: January 16, 2012

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Supportive Care
Condition:	Gastric Outlet Obstruction
Intervention:	Device: Cook Magnetic Anastomosis Device (MAD) with Stent

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Magnetic Anastomosis Device (MAD) With Stent	Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.

Participant Flow: Overall Study

	Magnetic Anastomosis Device (MAD) With Stent
STARTED	18
COMPLETED	12
NOT COMPLETED	6
Unsuccessful magnet placements	3
Death due to progressive malignancy	2
Stent not placed	1

Baseline Characteristics

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Reporting Groups

	Description
Magnetic Anastomosis Device (MAD) With Stent	Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.

Baseline Measures

	Magnetic Anastomosis Device (MAD) With Stent
Number of Participants [units: participants]	18
Age [units: years] Mean ± Standard Deviation	68.3 ± 11
Gender [units: participants]
Female	5
Male	13
Karnofsky Score ^[1] [units: Units on a scale] Mean ± Standard Deviation	72.2 ± 9.4
Presenting Condition [units: participants]
Cholangio cancer	3
Gastric cancer	1
Pancreatic cancer	12
Other	2
Current Treatments [units: participants]
Chemotherapy	4
Radiotherapy	0
Brachytherapy	0
No treatment - Palliative care only	10
Other	1
Patients with no current treatments	3

[1]	The Karnofsky score allows patients to be classified as to their functional impairment. It runs from 100 to 0, where 100 is “perfect” health and 0 is death.

Outcome Measures

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1. Primary:

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 [ Time Frame: Approximately 8-10 days ]

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2. Post-Hoc:

Success Rate of Mature Anastomosis Creation Using Magnetic Anastomosis Device (MAD) [ Time Frame: Approximately 8-10 days ]

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Serious Adverse Events

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Time Frame	No text entered.
Additional Description	Only 12 of 18 patients are reported in the reported Adverse Events section as "Total Number of Participants at Risk". These are the participants that received both the magnets and the stent (primary success).

Reporting Groups

	Description
Magnetic Anastomosis Device (MAD) With Stent	Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.

Serious Adverse Events

	Magnetic Anastomosis Device (MAD) With Stent
Total, serious adverse events
# participants affected / at risk	10/12 (83.33%)
Blood and lymphatic system disorders
Death ^[1]
# participants affected / at risk	1/12 (8.33%)
# events	1
Cardiac disorders
Death ^[2]
# participants affected / at risk	1/12 (8.33%)
# events	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death ^[3]
# participants affected / at risk	8/12 (66.67%)
# events	8

[1]	Death was due to peritonitis/sepsis subsequent to stent migration.
[2]	Death was due to co-morbidity.
[3]	Deaths were due to progressive malignancy.

Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Each PI/site is restricted from making any publication until the multi-center publication has been presented (published) or 12 months after conclusion/abandonment/or termination of the Study (in the case where the multi-center publication has not been submitted within the 12 months) or Cook confirms there will be no multi-center publication.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Enrollment was stopped in Feb 2009, due to the death of a patient after distal stent migration.

Results Point of Contact:

Name/Title: Scott Snyder, Ph.D., Manager, Biostatistics and Data Management, Senior Statistician
Organization: MED Institute, Inc.
phone: 765-463-7537
e-mail: ssnyder@medinst.com

No publications provided

Responsible Party:	Cook
ClinicalTrials.gov Identifier:	NCT00487552 History of Changes
Other Study ID Numbers:	06-014, 900000
Study First Received:	June 15, 2007
Results First Received:	January 16, 2012
Last Updated:	June 21, 2012
Health Authority:	Netherlands: Medical Ethics Review Committee (METC) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Belgium: Institutional Review Board Italy: Ethics Committee

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