Magnamosis First-in-human Study of Feasibility and Safety
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 10/13/2018 |
| Start Date: | May 1, 2014 |
| End Date: | June 2020 |
| Contact: | Michael R Harrison, MD |
| Email: | michael.harrison@ucsf.edu |
| Phone: | 415 476-4914 |
Magnetic Compression Anastomosis (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, 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.
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.
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
We found this trial at
2
sites
San Francisco, California 94158
Principal Investigator: Madhulika (Mika) Varma, MD
Phone: 415-885-3611
Click here to add this to my saved trials
San Francisco, California 94143
Principal Investigator: Stan Rogers, MD
Phone: 415-476-4914
Click here to add this to my saved trials