Intestinal Anastomosis ComplicationMagnamosisNCT02043392
Magnamosis First-in-human Study of Feasibility and Safety
A study testing Magnamosis in people with Intestinal Anastomosis Complication, run by Michael Harrison at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intestinal Anastomosis Complication
- What is being tested?
- Magnamosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2014to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, San Francisco - Parnassus Campus
San Francisco, California, 94143
UCSF-Mission Bay
San Francisco, California, 94158
About this study
Official title: 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.
Read the 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.
- Conditions
- Intestinal Anastomosis Complication
- Being tested
- Magnamosis
- Keywords
- intestinal anastomosis, non-emergent, intestinal revision, magnetic compression, anastomotic leak
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnamosisDevice
Also called Magnetic Compression Anastomosis
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Magnamosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 2 years postoperation
Secondary outcomes (2)
Number of subjects who experience other device-related complications
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
Measured: Up to 2 years postoperation
Number of patients who have an adequate anastomosis
Determine if anastomosis using Magnamosis is adequate. Follow-up will be at 2 weeks, 1 and 3 months, and 1 and 2 years postoperation.
Measured: Up to 2 years postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study start1 May 2014
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intestinal Anastomosis ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Harrison
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor-investigator, Michael Harrison, University of California, San Francisco
- Investigators
- Michael R Harrison, MD, Principal investigator, UCSF Professor Emeritus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043392
- Sponsor's protocol ID
- 13-11536
- Acronym
- Magnamosis
- Status last verified
- Jun 2023
- First submitted
- 17 Jan 2014
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 19159747Pichakron 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.
PubMed 21184956Gonzales 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.
PubMed 22703808Wall 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.
PubMed 23807805Graves 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.
PubMed 28843832
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Compression Anastomosis (Magnamosis) First-in-human Study of Feasibility and Safety
- ClinicalTrials.gov ID
- NCT02043392
- Acronym / sponsor ID
- Magnamosis / 13-11536
- Conditions
- Intestinal Anastomosis Complication
- Keywords
- intestinal anastomosis, non-emergent, intestinal revision, magnetic compression, anastomotic leak
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Michael HarrisonUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 1 May 2014 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnamosis | Experimental | Device: MagnamosisCreate 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- Intestines to be anastomosed are not appropriate in size, thickness or tissue health for the Magnamosis device. For example,
- Requires anastomosis of the stomach
- Bowel is not well perfused
- Anastomosis will be under tension
- Anatomic reconstruction requires crossing a staple line
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagnamosisAlso: Magnetic Compression AnastomosisSingle-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. | Device | Magnamosis |
Primary outcome
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
2 secondary outcomes
Number of subjects who experience other device-related complications
Time frame: Up to 2 years postoperation
Number of patients who have an adequate anastomosis
Time frame: Up to 2 years postoperation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Background: PubMed 19159747Jamshidi 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.
- Background: PubMed 21184956Pichakron 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.
- Background: PubMed 22703808Gonzales 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.
- Background: PubMed 23807805Wall 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.
- Results publication: PubMed 28843832Graves 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.
- website with device informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael R Harrison, MD principal investigator
UCSF Professor Emeritus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnamosis in people with Intestinal Anastomosis Complication, run by Michael Harrison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects who experience occurrence of anastomotic leak (time frame: Up to 2 years postoperation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02043392, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.