Trial Outcomes & Findings for Magnetic Anastomosis Device Relief of Malignant Gastric Outlet Obstruction (NCT NCT00487552)

NCT ID: NCT00487552

Last Updated: 2017-08-23

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: Approximately 8-10 days
• Results posted on: 2017-08-23

Participant Flow

Participant milestones

Measure	Magnetic Anastomosis Device (MAD) With Stent Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
Overall Study STARTED	18
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Magnetic Anastomosis Device (MAD) With Stent Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
Overall Study Unsuccessful magnet placements	3
Overall Study Death due to progressive malignancy	2
Overall Study Stent not placed	1

Baseline Characteristics

Magnetic Anastomosis Device Relief of Malignant Gastric Outlet Obstruction

Baseline characteristics by cohort

Measure	Magnetic Anastomosis Device (MAD) With Stent n=18 Participants Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
Karnofsky Score	72.2 Units on a scale STANDARD_DEVIATION 9.4 • n=5 Participants
Presenting Condition Cholangio cancer	3 participants n=5 Participants
Presenting Condition Gastric cancer	1 participants n=5 Participants
Presenting Condition Pancreatic cancer	12 participants n=5 Participants
Presenting Condition Other	2 participants n=5 Participants
Current Treatments Chemotherapy	4 participants n=5 Participants
Current Treatments Radiotherapy	0 participants n=5 Participants
Current Treatments Brachytherapy	0 participants n=5 Participants
Current Treatments No treatment - Palliative care only	10 participants n=5 Participants
Current Treatments Other	1 participants n=5 Participants
Age, Continuous	68.3 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Current Treatments Patients with no current treatments	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 8-10 days

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

Outcome measures

Measure	Magnetic Anastomosis Device (MAD) With Stent n=18 Participants Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
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	12 participants

POST_HOC outcome

Timeframe: Approximately 8-10 days

Population: Patients who underwent a second endoscopy after successful magnet placement

Endoscopy was performed to determine whether an anastomosis (hole) was successfully created.

Outcome measures

Measure	Magnetic Anastomosis Device (MAD) With Stent n=13 Participants Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
Success Rate of Mature Anastomosis Creation Using Magnetic Anastomosis Device (MAD)	13 participants

Adverse Events

Magnetic Anastomosis Device (MAD) With Stent

Serious events: 10 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Magnetic Anastomosis Device (MAD) With Stent n=12 participants at risk Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
Blood and lymphatic system disorders Death	8.3% 1/12 • Number of events 1 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).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death	66.7% 8/12 • Number of events 8 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).
Cardiac disorders Death	8.3% 1/12 • Number of events 1 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).

Other adverse events

Measure	Magnetic Anastomosis Device (MAD) With Stent n=12 participants at risk Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
Gastrointestinal disorders Migration	33.3% 4/12 • Number of events 4 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).

Additional Information

Scott Snyder, Ph.D., Manager, Biostatistics and Data Management, Senior Statistician

MED Institute, Inc.

Phone: 765-463-7537

Email: ssnyder@medinst.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER