Only 42 spots left

~42 spots leftby Dec 2025

xBar System for Detecting Anastomotic Leaks

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Exero Medical Ltd.

Disqualifiers: Pregnancy, Electronic implants, Major illness, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

Purpose: To validate the safety and effectiveness of xBar monitoring tool for detection of post-operative anastomotic leaks in subjects undergoing rectal/sigmoid resections with anastomosis. The clinical team is blinded to the leak detection of the xBar system.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the xBar System treatment for detecting anastomotic leaks?

The research on the biofragmentable anastomotic ring (BAR), which is similar in concept to the xBar System, shows that it is a safe and reliable alternative to conventional methods in colonic surgery, with low rates of anastomotic leaks and complications.¹ ² ³ ⁴ ⁵

How does the xBar System for Detecting Anastomotic Leaks differ from other treatments for anastomotic leaks?

The xBar System is unique because it uses a biofragmentable anastomotic ring (BAR) that allows for sutureless anastomosis, which can reduce the risk of leaks compared to traditional suturing methods. The BAR is made of polyglycolic acid, which fragments and is naturally passed by the body, offering a potentially safer and more cost-effective alternative to conventional techniques.¹ ² ⁶ ⁷ ⁸

Research Team

Eligibility Criteria

This trial is for adults aged 22 or older who are undergoing rectal/sigmoid resection surgery and will have a drain used during the procedure. Participants must be able to follow the study's schedule and give informed consent. Those with contraindications to surgery, pregnant or lactating individuals, people with certain implants like pacemakers, or those in another interventional study can't join.

Inclusion Criteria

A drain will be used during my surgery, as decided by my surgeon.

Willing and able to comply with the study follow up.

Able and agree to provide an informed consent.

See 2 more

Exclusion Criteria

Pregnancy or lactation.

Participation in another interventional study during the xBar system usage.

Major medical or psychiatric illness or condition, or other factors that may affect general health or ability to adhere to the follow-up schedule.

See 4 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Placement of the xBar device during colorectal surgery and commencement of data recording

3 days

1 visit (in-person)

Monitoring

Post-operative monitoring using the xBar system for early detection of anastomotic leaks

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

xBar System (Procedure)

Trial OverviewThe xBar system is being tested as a monitoring tool for detecting anastomotic leaks after colorectal surgeries. The effectiveness and safety of this device will be assessed while the clinical team remains unaware of its leak detection results.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Singel armExperimental Treatment1 Intervention

All patients will be treated with the investigational device.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:

University of LouisvilleLouisville, KY

Bryan Medical CenterLincoln, NE

Stony Brook University Hospital and Cancer CenterNew York, NY

Mount Sinai Health SystemNew York, NY

More Trial Locations

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Who Is Running the Clinical Trial?

Exero Medical Ltd.

Lead Sponsor

Trials

Patients Recruited

200+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results using the biofragmentable anastomotic ring for colon anastomosis.Wood, JS., Frost, DB.[2006]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colonic anastomosis using the biofragmentable anastomotic ring and manual suture: a prospective, randomized study.Gullichsen, R., Havia, T., Ovaska, J., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of compression anastomosis devices in digestive surgery].Fantini, C., Gauthier, P., Pastore, S., et al.[2007]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The burden of gastrointestinal anastomotic leaks: an evaluation of clinical and economic outcomes.Hammond, J., Lim, S., Wan, Y., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical use of a new compression surgical stapler in surgery of the large intestine].Rosati, R., Rebuffat, C., Fumagalli, U., et al.[2007]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoluminal Vacuum Therapy for Ivor Lewis Anastomotic Leaks: A Pilot Study in a Swine Model.Scott, RB., Ritter, LA., Shada, AL., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The biofragmentable ring in intestinal surgery.Gullichsen, R.[2004]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with the biofragmentable anastomotic ring (BAR) in bowel preoperatively irradiated with 6000 rad.Croston, JK., Jacobs, DM., Kelly, PH., et al.[2019]