Magnetic Compression Anastomosis (Magnamosis) First-in-human Study of Feasibility and Safety

Status: Completed
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
UCSF-Mission Bay
San Francisco
University of California, San Francisco - Parnassus Campus
San Francisco
Time Frame
Start Date: 2014-05-01
Completion Date: 2017-11
Participants
Target number of participants: 5
Treatments
Experimental: Magnamosis
Create an intestinal anastomosis using the Magnamosis Magnetic Compression Anastomosis (Magnamosis) device to re-establish intestinal continuity that would otherwise be performed using sutures or stapling devices
Authors
Madhulika (Mika) Varma, Marshall Stoller, Hobart Harris, Thomas Chi
Related Therapeutic Areas
Sponsors
Collaborators: University of California, San Francisco
Leads: Michael Harrison

This content was sourced from clinicaltrials.gov