Magnamosis First-in-human Study of Feasibility and Safety

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02043392
First received: January 17, 2014
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Intestinal Anastomosis for Intestinal Continuity
Device: Magnamosis
Phase 1

Study Type: Interventional
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

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 10
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)
Arms Assigned Interventions
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
Device: Magnamosis
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043392

Contacts
Contact: Michael R Harrison, MD 415 476-4914 michael.harrison@ucsfmedctr.org
Contact: Jill Imamura-Ching, RN 415 502-0169 jill.imamura-ching@ucsfmedctr.org

Locations
United States, California
University of California, San Francisco - Parnassus Campus Recruiting
San Francisco, California, United States, 94143
Contact: Michael R. Harrison, MD    415-476-4914    michael.harrison@ucsfmedctr.org   
Contact: Jill Imamura-Ching, RN    415-502-0169    jill.imamura-ching@ucsfmedctr.org   
Principal Investigator: Stan Rogers, MD         
UCSF-Mt. Zion Hospital Recruiting
San Francisco, California, United States, 94143
Contact: Madhulika Varma, MD    415-885-3606    madhulika.varma@ucsfmedctr.org   
Contact: Jessica Rhee    415 353-7252    Jessica.Rhee@ucsfmedctr.org   
Principal Investigator: Madhulika (Mika) Varma, MD         
Sponsors and Collaborators
University of California, San Francisco
  More Information

Additional Information:
Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02043392     History of Changes
Other Study ID Numbers: 13-11536
Study First Received: January 17, 2014
Last Updated: September 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
intestinal anastomosis
non-emergent
intestinal continuity
magnetic compression
anastomotic leak

ClinicalTrials.gov processed this record on September 18, 2014