xBar System for Detecting Anastomotic Leaks

Recruiting at 11 trial locations

Overseen By Gal Levi

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

Trial Summary

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}

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.

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.

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

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

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Results using the biofragmentable anastomotic ring for colon anastomosis. [2006]

2. England pubmed.ncbi.nlm.nih.gov

Colonic anastomosis using the biofragmentable anastomotic ring and manual suture: a prospective, randomized study. [2019]

3. Italy pubmed.ncbi.nlm.nih.gov

[Use of compression anastomosis devices in digestive surgery]. [2007]

4. United States pubmed.ncbi.nlm.nih.gov

The burden of gastrointestinal anastomotic leaks: an evaluation of clinical and economic outcomes. [2022]

5. Italy pubmed.ncbi.nlm.nih.gov

[Clinical use of a new compression surgical stapler in surgery of the large intestine]. [2007]

6. United States pubmed.ncbi.nlm.nih.gov

Endoluminal Vacuum Therapy for Ivor Lewis Anastomotic Leaks: A Pilot Study in a Swine Model. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The biofragmentable ring in intestinal surgery. [2004]

8. United States pubmed.ncbi.nlm.nih.gov

Experience with the biofragmentable anastomotic ring (BAR) in bowel preoperatively irradiated with 6000 rad. [2019]