Magnamosis First-in-human Study of Feasibility and Safety
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, duodeno-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.
Intestinal Anastomosis for Intestinal Continuity
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Magnetic Compression Anastomosis (Magnamosis) First-in-human Study of Feasibility and Safety|
- Number of subjects who experience occurrence of anastomotic leak [ Time Frame: Up to 2 years postoperation ] [ Designated as safety issue: Yes ]Subject follow-up will be performed at postoperation 2 weeks, 1 and 3 months, 1 and 2 years to assess the occurrence of an anastomotic leak
- Number of subjects who experience other device-related complications [ Time Frame: Up to 2 years postoperation ] [ Designated as safety issue: Yes ]Other device-related complications include stricture, obstruction, bleeding, delayed expulsion of the device, device failure, bowel perforation will be assessed at 2 weeks, 1 and 3 months, and 1 and 2 years postoperation
- Number of patients who have an adequate anastomosis [ Time Frame: Up to 2 years postoperation ] [ Designated as safety issue: No ]Determine if anastomosis using Magnamosis is adequate. Follow-up will be at 2 weeks, 1 and 3 months, and 1 and 2 years postoperation.
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
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
Single-use, sterile device enables creation of a circular compression intestinal anastomosis. Device is comprised of matched pair of self-centering rare earth ring magnets encased in medical grade polycarbonate. Geometry of magnets' mating surfaces applies enough 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 permits immediate patency of the anastomosis to prevent intestinal obstruction during compression anastomosis creation. In 5-10 days, mated rings with intervening necrotic tissue falls into intestinal lumen and is naturally expelled with stool, leaving a well-healed anastomosis. Magnamosis device can be delivered by standard open, laparoscopic, or endoscopic techniques, depending on approach required by index procedure.
Other Name: Magnamosis Magnetic Compression Anastomosis device
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02043392
|Contact: Michael R Harrison, MD||415 firstname.lastname@example.org|
|Contact: Jill Imamura-Ching, RN||415 email@example.com|
|United States, California|
|UCSF-Mt. Zion Hospital||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Madhulika Varma, MD 415-885-3606 firstname.lastname@example.org|
|Contact: Jessica Rhee 415 353-7252 Jessica.Rhee@ucsfmedctr.org|
|Principal Investigator: Madhulika (Mika) Varma, MD|
|University of California, San Francisco - Parnassus Campus||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Michael R. Harrison, MD 415-476-4914 email@example.com|
|Contact: Jill Imamura-Ching, RN 415-502-0169 firstname.lastname@example.org|
|Principal Investigator: Stan Rogers, MD|