Magnamosis First-in-human Study of Feasibility and Safety

Completed · Not applicable

Conditions studied: Intestinal Anastomosis Complication

In brief

Anastomosis of intestine or other viscera currently requires open or laparoscopic surgery and is often the most difficult, time-consuming, and expensive part of many operations. We have developed a device ("Magnamosis") that may create compression anastomoses more easily, quickly, and less expensively than sutures or staples. The Magnamosis device consists of two 23-mm diameter, convex-concave, radially symmetric ring magnets encased in polycarbonate. One magnet is placed in the lumen of each viscus to be joined, the magnets self-align, and a compression anastomosis is achieved by tissue remodeling. We have completed extensive pre-clinical studies in animals and have shown that Magnamosis can be used to accomplish gastrojejunostomy, jejunojejunostomy, duodenal-colostomy, and colo-colostomy safely and effectively using available endoscopic and minimally invasive surgery techniques. We are now conducting a small first-in-human study to obtain clinical data in support of the safety and early feasibility of the Magnamosis device.

Key facts

Study ID

NCT02043392

Run by

Michael Harrison

People needed

5

Starts

2014-05-01

Expected to finish

2017-11-01

Last updated by the study team

2023-06-15

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Between 18 and ≤ 60 years of age
• Requires non-emergent operation to create an intestinal anastomosis for maintenance of intestinal continuity in which the Magnamosis device can be used instead of sutures or staples.
• Able to read, speak and understand English
• Demonstrates an understanding of the study procedures and risks, and can provide signed informed consent.

You may not qualify if…

• Intestines to be anastomosed are not appropriate in size, thickness or tissue health for the Magnamosis device. For example,
• Intestine too small to accommodate 23-mm diameter device; or
• Intestine so large that 23-mm diameter anastomotic lumen is not adequate; or
• Intestine too thickened to allow two halves of device to come together with sufficient force to produce compression anastomosis (e.g. inflamed or scarred intestinal wall; a foreign body like staples in anastomosis); or
• Inadequate blood supply
• Requires anastomosis of the stomach
• Bowel is not well perfused
• Anastomosis will be under tension
• Anatomic reconstruction requires crossing a staple line
• ASA (American Society of Anesthesiology) score 4 or 5;
• Requires more than one anastomosis during operation;
• Women possibly or known to be pregnant;
• Inability to obtain pre-authorization from insurance company or third party payor
• Does not meet all inclusion criteria

Where it is running

• University of California, San Francisco - Parnassus Campus — San Francisco, California, United States
• UCSF-Mission Bay — San Francisco, California, United States

Full record on ClinicalTrials.gov

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