xBar System for Detecting Anastomotic Leaks

Recruiting at 16 trial locations

Overseen By Erez Shor, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Exero Medical Ltd.

Disqualifiers: Pregnancy, Electronic implants, Major illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 3 days

190 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new monitoring tool, the xBar System, to determine if it can safely and effectively detect leaks after certain bowel surgeries. It focuses on patients who have undergone operations involving the rectum or sigmoid colon, specifically surgeries where the bowel is reconnected. The trial seeks participants scheduled for these surgeries who will have a surgical drain used. The goal is to ensure the xBar System helps doctors catch post-surgery leaks early, potentially improving recovery and outcomes. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance post-surgical care and recovery.

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 prior data suggests that the xBar System is safe for detecting anastomotic leaks?

Research has shown that the xBar System, a tool for detecting leaks after colon surgery, was tested in a study with 50 patients who had part of their colon removed. In that study, the xBar System successfully detected leaks early.

No safety issues or negative effects have been directly linked to the xBar System so far. Unlike typical trials for new drugs or treatments, this trial considers the device safe enough for further testing in real-life situations. The primary goal is to evaluate the system's effectiveness in detecting leaks, not to assess its safety.

For those considering joining this trial, current data suggests that the xBar System is well-tolerated based on previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The xBar System is unique because it offers a novel approach to detecting anastomotic leaks, which are serious complications following surgeries like bowel resection. Unlike traditional methods that rely on clinical observation and imaging techniques, the xBar System uses advanced sensor technology to provide real-time monitoring. This could lead to earlier detection of leaks, potentially improving patient outcomes and reducing recovery time. Researchers are excited because this system might offer a more immediate and accurate way to identify complications, leading to quicker interventions and better overall care.

What evidence suggests that the xBar System is effective for detecting anastomotic leaks?

Research has shown that the xBar System is being tested in this trial to determine its effectiveness in detecting leaks after colon or rectal surgery. Designed to monitor patients and identify leaks early, this system addresses a serious concern. Although specific performance details are not yet available, the system aims to provide doctors with critical information directly from the surgery site. This could help prevent complications by alerting doctors to issues before they escalate. Early detection is crucial for patient recovery and safety. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• xBar System

Trial Overview The 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.

How Is the Trial Designed?

Group I: Singel arm Experimental Treatment 1 Intervention

All patients will be treated with the investigational device.

Who Is Running the Clinical Trial?

Exero Medical Ltd.

Lead Sponsor

Trials

2

Recruited

200+

Published Research Related to This Trial

The Biofragmentable Anastomotic Ring (BAR) was used successfully in 47 patients for colonic anastomosis without any anastomotic leaks or complications, demonstrating its safety and efficacy in this surgical application.

The BAR offers a cost advantage over traditional stapling techniques, as it is equivalent in price to a single stapler while potentially reducing overall costs since fewer devices are needed for the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Anastomotic leaks occur in 6.18% of patients after colorectal surgery and significantly increase the risk of 30-day re-admissions and postoperative infections, with rates 1.3 times and 0.8-1.9 times higher, respectively.

The economic impact of anastomotic leaks is substantial, leading to an average increase of 7.3 days in hospital stay and an additional cost of $24,129 per patient, resulting in an estimated total burden of $28.6 million for 1,000 patients undergoing colorectal surgery.

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]

The Biofragmentable Anastomosis Ring (BAR) was evaluated in a study involving 14 dogs and 150 patients, showing that it can be used effectively for colonic anastomoses with similar healing outcomes compared to traditional sutured methods.

In clinical trials, BAR anastomoses had comparable rates of anastomotic leakage and recovery times to sutured anastomoses, indicating its potential as a safe and effective alternative for gastrointestinal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

In a study involving 13 dogs that underwent preoperative irradiation of 6000 rad, the biodegradable anastomotic ring (BAR) showed a significantly lower rate of anastomotic leaks (3 out of 13) compared to sutured (7 out of 10) and stapled (8 out of 10) methods, indicating its potential safety in high-radiation settings.

The results suggest that the BAR may enhance the safety of surgical anastomoses after irradiation, although the exact mechanism—whether due to its atraumatic placement or improved blood flow—remains unclear.

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]

In a study involving 95 patients undergoing large bowel anastomosis with a new compression anastomotic device, the device demonstrated a low operative mortality rate of 1.0% and minimal postoperative discomfort, with rings evacuated after an average of 10.9 days.

The anastomotic device showed a low complication rate, with only 5.2% of patients experiencing clinical leakages and no cases of hemorrhage or stenosis, indicating its reliability for colorectal surgery.

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]

In a study involving 10 pigs with a 1-cm esophageal anastomotic defect, the use of endoluminal negative pressure vacuum devices successfully prevented leaks, while all control pigs showed significant leakage and contamination.

The results suggest that this therapy is well-tolerated and could lead to reduced complications and shorter hospital stays in clinical settings, with a statistically significant P value of 0.03 indicating the effectiveness of the treatment.

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]

In a study involving 26 patients undergoing digestive surgery, the new biofragmentable ring device (BAR-Valtrac) was used for various anastomoses, and there were no perioperative deaths or complications such as leakage, bleeding, or obstruction.

Follow-up endoscopic evaluations at six months showed no anastomotic stenoses in 50% of patients, indicating that Valtrac anastomoses are safe and potentially as effective, if not better, than traditional stapled anastomoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

In a study of 150 patients undergoing colonic surgery, the biofragmentable anastomotic ring (BAR) showed a lower mortality rate (1%) compared to the hand-suture method (6%), suggesting it may be a safer option.

Both methods resulted in similar recovery times and hospital stays, indicating that the BAR is a reliable alternative to traditional suturing for colonic anastomosis.

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06168669

Study Details | NCT06168669 | A Safety and Effectiveness ... Purpose: To validate the safety and effectiveness of xBar monitoring tool for detection of post-operative anastomotic leaks in subjects undergoing rectal/ ...

2. prnewswire.com prnewswire.com/il/news-releases/exero-medical-completes-enrollment-of-222-patient-us-pivotal-study-for-early-detection-of-post-operative-gastrointestinal-surgery-complications-302557619.html

Exero Medical Completes Enrollment of 222-Patient U.S. ... The study, designed to validate the safety and effectiveness of the xBar system for early detection of anastomotic leaks following colorectal ...

3. jcto.weill.cornell.edu jcto.weill.cornell.edu/open_clinical_trials/a-safety-and-effectiveness-prospective-blinded-clinical-study-to-validate-xbar-system-as-monitoring-tool-for-anastomotic-leaks-detection

A Safety and Effectiveness Prospective Blinded clinical ... The study is intended to validate the performance of the xBar system's anastomotic leak detection monitoring tool following colorectal resection with drain ...

4. exeromedical.com exeromedical.com/

Exero Medical – Monitor. Detect. Intervene Exero's xBar system empowers health care providers with high-quality, actionable post-operative data directly from the surgical site.

5. ctv.veeva.com ctv.veeva.com/study/a-safety-and-effectiveness-prospective-blinded-clinical-study-to-validate-xbar-system-as-monitoring

A Safety and Effectiveness Prospective Blinded Clinical Study ... Purpose: To validate the safety and effectiveness of xBar monitoring tool for detection of post-operative anastomotic leaks in subjects undergoing ...

6. exeromedical.com exeromedical.com/technology/

Technology A multi-center pilot study of 50 anterior resection patients monitored with the xBar system post-operatively demonstrated leak detection with ...

7. medicaldevice-network.com medicaldevice-network.com/news/exero-medical-us-study-xbar-system/

Exero Medical completes enrolment for US study of xBar ... Its sensor continuously monitors the anastomosis area to facilitate early detection of anastomotic leaks. These leaks are a common, severe ...