NCT02043392

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

3.5 years

First QC Date

January 17, 2014

Last Update Submit

June 12, 2023

Conditions

Intestinal Anastomosis Complication

Keywords

intestinal anastomosisnon-emergentintestinal revisionmagnetic compressionanastomotic leak

Outcome Measures

Primary Outcomes (1)

  • Number of subjects who experience occurrence of anastomotic leak

    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

    Up to 2 years postoperation

Secondary Outcomes (2)

  • Number of subjects who experience other device-related complications

    Up to 2 years postoperation

  • Number of patients who have an adequate anastomosis

    Up to 2 years postoperation

Study Arms (1)

Magnamosis

EXPERIMENTAL

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

Interventions

MagnamosisDEVICE

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.

Also known as: Magnetic Compression Anastomosis
Magnamosis

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, San Francisco - Parnassus Campus

San Francisco, California, 94143, United States

Location

UCSF-Mission Bay

San Francisco, California, 94158, United States

Location

Related Publications (5)

  • Jamshidi R, Stephenson JT, Clay JG, Pichakron KO, Harrison MR. Magnamosis: magnetic compression anastomosis with comparison to suture and staple techniques. J Pediatr Surg. 2009 Jan;44(1):222-8. doi: 10.1016/j.jpedsurg.2008.10.044.

    PMID: 19159747BACKGROUND

  • Pichakron KO, Jelin EB, Hirose S, Curran PF, Jamshidi R, Stephenson JT, Fechter R, Strange M, Harrison MR. Magnamosis II: Magnetic compression anastomosis for minimally invasive gastrojejunostomy and jejunojejunostomy. J Am Coll Surg. 2011 Jan;212(1):42-9. doi: 10.1016/j.jamcollsurg.2010.09.031.

    PMID: 21184956BACKGROUND

  • Gonzales KD, Douglas G, Pichakron KO, Kwiat DA, Gallardo SG, Encinas JL, Hirose S, Harrison MR. Magnamosis III: delivery of a magnetic compression anastomosis device using minimally invasive endoscopic techniques. J Pediatr Surg. 2012 Jun;47(6):1291-5. doi: 10.1016/j.jpedsurg.2012.03.042.

    PMID: 22703808BACKGROUND

  • Wall J, Diana M, Leroy J, Deruijter V, Gonzales KD, Lindner V, Harrison M, Marescaux J. MAGNAMOSIS IV: magnetic compression anastomosis for minimally invasive colorectal surgery. Endoscopy. 2013 Aug;45(8):643-8. doi: 10.1055/s-0033-1344119. Epub 2013 Jun 27.

    PMID: 23807805BACKGROUND

  • Graves CE, Co C, Hsi RS, Kwiat D, Imamura-Ching J, Harrison MR, Stoller ML. Magnetic Compression Anastomosis (Magnamosis): First-In-Human Trial. J Am Coll Surg. 2017 Nov;225(5):676-681.e1. doi: 10.1016/j.jamcollsurg.2017.07.1062. Epub 2017 Aug 23.

    PMID: 28843832RESULT

Related Links

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael R Harrison, MD

    UCSF Professor Emeritus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Surgery

Study Record Dates

First Submitted

January 17, 2014

First Posted

January 23, 2014

Study Start

May 1, 2014

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)