This trial is testing a new device to close the small intestine after an ileostomy reversal, to see if it is safe and effective compared to conventional methods.
1 Primary · 0 Secondary · Reporting Duration: 30 days
Awards & Highlights
2 Treatment Groups
Retrospective Chart Review of Historical Controls
1 of 2
Prospective Evaluation of the SFM Device
1 of 2
400 Total Participants · 2 Treatment Groups
Primary Treatment: Ileostomy Reversal using Self Forming Magnets (SFM) · No Placebo Group · N/A
Who is running the clinical trial?
Age 18 - 80 · All Participants · 1 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
Frequently Asked Questions
What sort of individuals might qualify as participants in this experiment?
"This clinical trial is recruiting 400 individuals from the age of 18 up to 80, whose ileostomy has been retracted. Prospective participants must meet certain prerequisites which include: surpassing the age of majority, a temporary loop ileostomy established within 2-10 months before reversal and BMI ≤ 40 kg/m2, with an American Society of Anesthesiologist (ASA) score < IV at time of reversal. In addition, cancer patients need to have completed chemotherapy ≥2 months prior to ileostomy closure. Furthermore, all involved parties should be aware that they are participating in this study as well as follow protocol" - Anonymous Online Contributor
Is there an age cap for participants of this clinical experiment?
"This research is looking for volunteers aged 18-80." - Anonymous Online Contributor
What is the uppermost limit of participants involved in this medical experiment?
"In order to progress this medical trial, 400 qualified patients need to be enrolled. Those who meet the criteria can participate in locations such as Vanderbilt University Medical Center, located in Nashville Tennessee and The Medical College of Wisconsin based in Milwaukee Wisconsin." - Anonymous Online Contributor
At what number of healthcare centers is this experiment being conducted?
"Patients can enroll in this medical trial at several locations, including Vanderbilt University Medical Center (Nashville, Tennessee), The Medical College of Wisconsin (Milwaukee, Wisconsin), and Dartmouth Hitchcock Medical Center (Lebanon, New Hampshire). Additionally there are 8 other sites available." - Anonymous Online Contributor
Is this investigation currently recruiting participants?
"Affirmative. Per the data hosted on clinicaltrials.gov, this medical trial is currently enrolling participants and was first posted on February 1st 2022 before being updated last October 24th 2022. 400 individuals are expected to be recruited from 11 different hospitals." - Anonymous Online Contributor