Magnamosis First-in-human Study of Feasibility and Safety (Magnamosis)
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ClinicalTrials.gov Identifier: NCT02043392 |
Recruitment Status : Unknown
Verified May 2020 by Michael Harrison, University of California, San Francisco.
Recruitment status was: Recruiting
First Posted : January 23, 2014
Last Update Posted : May 29, 2020
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Condition or disease | Intervention/treatment | Phase |
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Intestinal Anastomosis Complication | Device: Magnamosis | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Magnetic Compression Anastomosis (Magnamosis) First-in-human Study of Feasibility and Safety |
Actual Study Start Date : | May 1, 2014 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2022 |
Arm | Intervention/treatment |
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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
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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 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.
Other Name: Magnetic Compression Anastomosis |
- Number of subjects who experience occurrence of anastomotic leak [ Time Frame: Up to 2 years postoperation ]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 ]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 ]Determine if anastomosis using Magnamosis is adequate. Follow-up will be at 2 weeks, 1 and 3 months, and 1 and 2 years postoperation.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043392
Contact: Michael R Harrison, MD | 415 476-4914 | michael.harrison@ucsf.edu | |
Contact: Jill Imamura-Ching, RN | 415 476-3446 | jill.imamura-ching@ucsf.edu |
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@ucsf.edu | |
Contact: Jill Imamura-Ching, RN 415-476-3446 jill.imamura-ching@ucsf.edu | |
Principal Investigator: Stan Rogers, MD | |
Principal Investigator: Marshall Stoller, MD | |
Sub-Investigator: Thomas Chi, MD | |
Sub-Investigator: Hobart Harris, MD | |
UCSF-Mission Bay | Recruiting |
San Francisco, California, United States, 94158 | |
Contact: Madhulika Varma, MD 415-885-3611 madhulika.varma@ucsf.edu | |
Contact: Jessica Rhee 415 353-7252 Jessica.Rhee@ucsf.edu | |
Principal Investigator: Madhulika (Mika) Varma, MD |
Principal Investigator: | Michael R Harrison, MD | UCSF Professor Emeritus |
Publications:
Responsible Party: | Michael Harrison, Professor, Surgery, University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT02043392 |
Other Study ID Numbers: |
13-11536 |
First Posted: | January 23, 2014 Key Record Dates |
Last Update Posted: | May 29, 2020 |
Last Verified: | May 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
intestinal anastomosis non-emergent intestinal revision magnetic compression anastomotic leak |