Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
NCT ID:
NCT02043392
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02043392
Study Brief:
Protocol Section:
NCT02043392