Magnamosis First-in-human Study of Feasibility and Safety
Condition: Intestinal Anastomosis Complication
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      This is a non-randomized, prospective, single-center pilot study to evaluate the feasibility
      and safety of creating an intestinal anastomosis using the Magnamosis Magnetic Compression
      Anastomosis (Magnamosis) device under FDA IDE G130046. Ten, otherwise healthy, subjects, ages
      18-60 years, with a disease process necessitating open or laparoscopic surgical anastomosis
      for re-establishment of intestinal continuity that would otherwise be performed using sutures
      or stapling devices will be enrolled. Participation in the study requires a time commitment
      of three months. The total duration of the study is 18 months to ensure three-month follow-up
      on each subject, with long-term follow-up of each subject at one and two years postoperation.
      The primary outcome measure will be the incidence of anastomotic leaks related to the use of
      the Magnamosis device. Anastomotic leakage will be defined as clinical symptoms such as
      fever, sepsis or peritonitis within 30 days postoperatively leading to a clinical and/or
      radiological interventional procedure or reoperation that confirms that the leakage is
      related to the device. Secondary outcome measures will include the rate of occurrence of
      other device-related complications during hospitalization and post-procedure, including the
      rate of bleeding, perforation, retention of foreign body, and anastomotic stricture
      documented by symptoms or imaging within three months of procedure. The duration of
      hospitalization, number of days to passage of Magnamosis device (found in stool or absent on
      x-ray), and number of days to the first postoperative bowel movement will also be measured.
      Post-operative administration of the pain scale will also yield study data. Subject follow-up
      will be conducted after discharge at 2 weeks (in person, in clinic), and at 1 month, 3
      months, 1 year and 2 years either in person, via email, telephone, Skype, or other non
      in-person method.
    

Intervention name(s): Magnamosis
Intervention type(s): Device
Intervention description(s): Single-use, sterile device enables creation of a circular compression intestinal anastomosis. Device is comprised of matched pair of self-centering rare earth magnets encased in medical grade polycarbonate. Geometry of magnets' mating surfaces applies force on inside of mated rings to produce compression necrosis of intervening intestinal walls. Lesser force on outside of mated rings produces inflammatory healing of the two co-apted intestinal walls. Internal lumen creates patency of the anastomosis to prevent intestinal obstruction during compression anastomosis creation. In 5-10 days, mated rings with necrotic tissue falls into intestinal lumen and is naturally expelled with stool, leaving a well-healed anastomosis.
Other intervention name(s): Magnetic Compression Anastomosis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: intestinal anastomosis; non-emergent; intestinal revision; magnetic compression; anastomotic leak