Colorectal CancerASSURENCT07337590
Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar
A study testing xBar™ System in people with Colorectal Cancer, run by Exero Medical Ltd. at 6 sites in United States.
Trial summary
Purpose: To evaluate the effect of xBar system utilization on clinical outcomes during recovery following colorectal surgery. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- xBar™ System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 6 sitesUnited States
- Study dates
- 10 Mar 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Interventional Cohort
- Adults (≥21 years) scheduled for elective low anterior resection (by any surgical technique), due to colorectal cancer
- Expected anastomosis within 10 cm from the anal verge
- Usage of drain during the surgery (to be confirmed during the surgery)
- Willing and able to comply with the study follow up and able and agree to provide informed consent.
- Historical Cohort
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- Adults aged ≥21 years at the time of surgery.
- Underwent a low anterior resection (LAR) for malignant colorectal disease.
- Documented colorectal anastomosis located <10cm from the anal verge, or documented tumor <10cm from the anal verge. Complete documentation for the index hospitalization and for the required 12-month follow-up period, or up to stoma take down procedure whichever came first.
Who cannot join
- Interventional Cohort
- Subjects with benign disease
- Contraindication for surgery and/or general anesthesia.
- Known pregnancy or lactation.
- Subjects receiving prophylactic stoma formation during index surgery (to be confirmed intraoperatively)
- Known electronic devices implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator).
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- Major medical or psychiatric illness or condition, or other factors that may affect general health or ability to adhere to the follow-up schedule.
- Known allergic reactions to materials used in the components of the xBar system, i.e., silicone, rubber and stainless-steel.
- Participation in another interventional study during the xBar system usage. Historical Cohort
- 1. LAR performed for benign or non-oncologic indications (e.g., diverticulitis, inflammatory bowel disease, non-malignant strictures, fistula).
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ruth Stone contact
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Jodie Frost, jfrost17@jhmi.edu
Andrea Bafford, MD, FACS, FASCRS
- Recruiting
Bryan Medical Center
Lincoln, Nebraska, 68506
Kristin Williams, kristin.williams@bryanhealth.org
Michael Jobst, MD
- Recruiting
University of Louisville Hospital
Louisville, Kentucky, 40202
Kiel Carson Butterfield, kiel.carsonbutterfield@louisville.edu
Sandra Kavalukas, MD
- Recruiting
Weill Cornell Medicine Colon and Rectal Surgery
New York, New York, 10021
KM Muktasid, 646-962-2789, kmm4010@med.cornell.edu
Mehraneh D Jafari, MD
- Not yet recruiting
Department of Colon and Rectal Surgery
New York, New York, 10075
Jonathan Gruberg, 212-434-4350, jgruberg@northwell.edu
Joseph Martz, MD
- Recruiting
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Amie Pietropola, 412-330-4567, Amie.Pietropola@ahn.org
James McCormick, MD
About this study
Purpose: To evaluate the effect of xBar system utilization on clinical outcomes during recovery following colorectal surgery.
Read the detailed description
The study is intended to evaluate the effect of xBar utilization on clinical outcomes during recovery from colorectal surgery. During the study, patients in the intervention group admitted for low anterior resection surgery will have xBar placed during their index surgery. The overall morbidity, healthcare utilization costs, and stoma utilization of the intervention group will be compared to those of the historical control group, consisting of patients meeting the same inclusion/exclusion criteria of the patients in the intervention group.
The xBar system, classified as a non-significant risk device in the pivotal study, is designed as an integrated platform for post-operative monitoring, built to fit into the existing clinical workflow without altering the standard surgical protocol.
- Conditions
- Colorectal Cancer
- Being tested
- xBar™ System
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xBar™ SystemDevice
Device: The xBar™ device functions by integrating a sensing electrode array into a standard surgical drain, thereby enabling monitoring without altering standard surgical protocols Description: The Exero Medical xBar™ System is designed to provide continuous postoperative monitoring of gastrointestinal (GI) anastomoses to support the early identification of anastomotic leaks. The device functions by integrating a sensing electrode array into a standard surgical drain, thereby enabling monitoring without altering standard surgical protocols.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Cohort | Experimental | The xBar drain will be placed during the elective low anterior resection, which will be performed according to each medical center's standard surgical procedures. Following placement, the xBar system will continuously collect measurements until drain removal. Receives: Device: xBar™ System |
| Historical Control Cohort | No intervention | A de-identified historical cohort consisting of a matched population that underwent surgical procedures during 2023. Historical data will include subject demographics, initial diagnosis, index surgery details, tumor location, comorbidities, length of stay (LOS), and readmission rates following the index colorectal surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint-Demonstrate non-inferiority between the study interventional and historical cohorts
Non-inferiority of the mean Modified Comprehensive Complication Index (MCCI) of the modified intent-to-treat (mITT) population at 30 days following the index surgery, compared with the MCCI of the matched historical cohort.
Measured: At the time points of 30 and 90 days following index surgery
Primary Safety Endpoint - No Unexpected Serious Adverse Device Events within the Intent to Treat population during the study period ( up to 365 days following index surgery)
Lack of unanticipated serious adverse events related to the xBar system or xBar procedure during the study period ( up to 365 days from the index surgery)
Measured: from the date of index surgery up to 365 days following the index surgery
Secondary outcomes (3)
Number of Stoma-Free patients during the study follow up
Comparison of the number of stoma-free patients in the intervention group vs. the historical cohort at postoperative day 30, postoperative day 90, 6 months, and 12 months. (in %)
Measured: Time points 30 days, 90 days, 6 months and 12 months following the index surgery
Sensitivity and specificity of xBar outcome
Evaluation of xBar's leak detection performance (Sensitivity, Specificity, Negative Predictive Value, Positive Predictive Value).
Measured: As from Visit 0 (Day of Surgery -drain placement) through the discharge visits (drain removal as per routine practice), anticipated average 3 days.
1. Comparison of MCCI Comorbidity Index (between study cohorts) 2. Number of Stome-Free patients during the study follow up 3. Sensitivity and specificity of xBar outcome
- Comparison of MCCI (Comorbidity Index) score based on National Surgical Quality Improvement Program scores, length of stay and readmission events at postoperative day 30 in the intervention group VS the historical cohort
- Comparison of percentages of stoma-free patients in the intervention group vs. the historical cohort at POD30, POD90, 6 months, and 12 months.
- Evaluation of xBar's leak detection performance (Sensitivity, Specificity, Negative Predictive Value, Positive Predictive Value).
Measured: At timepoints of 30, 90 ,180 and 365 days following the index surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start10 Mar 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study will include two cohorts: * Interventional Cohort: Approximately 80 eligible subjects with colorectal cancer undergoing elective low anterior resection with anastomosis, without concomitant diversion, who meet all study inclusion criteria and none of the exclusion criteria. * Historical Control Cohort: A de-identified historical cohort consisting of a matched population that underwent surgical procedures during 2023. Historical data will include subject demographics, initial diagnosis, index surgery details, tumor location, comorbidities, length of stay (LOS), and readmission rates following the index colorectal surgery.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exero Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337590
- Sponsor's protocol ID
- CLP 04
- Acronym
- ASSURE
- Status last verified
- Jun 2026
- First submitted
- 5 Dec 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar
- ClinicalTrials.gov ID
- NCT07337590
- Acronym / sponsor ID
- ASSURE / CLP 04
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Exero Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: To evaluate the effect of xBar system utilization on clinical outcomes during recovery following colorectal surgery.
Detailed description
The study is intended to evaluate the effect of xBar utilization on clinical outcomes during recovery from colorectal surgery. During the study, patients in the intervention group admitted for low anterior resection surgery will have xBar placed during their index surgery. The overall morbidity, healthcare utilization costs, and stoma utilization of the intervention group will be compared to those of the historical control group, consisting of patients meeting the same inclusion/exclusion criteria of the patients in the intervention group.
The xBar system, classified as a non-significant risk device in the pivotal study, is designed as an integrated platform for post-operative monitoring, built to fit into the existing clinical workflow without altering the standard surgical protocol.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will include two cohorts: * Interventional Cohort: Approximately 80 eligible subjects with colorectal cancer undergoing elective low anterior resection with anastomosis, without concomitant diversion, who meet all study inclusion criteria and none of the exclusion criteria. * Historical Control Cohort: A de-identified historical cohort consisting of a matched population that underwent surgical procedures during 2023. Historical data will include subject demographics, initial diagnosis, index surgery details, tumor location, comorbidities, length of stay (LOS), and readmission rates following the index colorectal surgery.
| Arm | Type | Receives |
|---|---|---|
| Interventional Cohort | Experimental | Device: xBar™ SystemThe xBar drain will be placed during the elective low anterior resection, which will be performed according to each medical center's standard surgical procedures. Following placement, the xBar system will continuously collect measurements until drain removal. |
| Historical Control Cohort | No intervention | –A de-identified historical cohort consisting of a matched population that underwent surgical procedures during 2023. Historical data will include subject demographics, initial diagnosis, index surgery details, tumor location, comorbidities, length of stay (LOS), and readmission rates following the index colorectal surgery. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Interventional Cohort
- Adults (≥21 years) scheduled for elective low anterior resection (by any surgical technique), due to colorectal cancer
- Expected anastomosis within 10 cm from the anal verge
- Usage of drain during the surgery (to be confirmed during the surgery)
- Willing and able to comply with the study follow up and able and agree to provide informed consent.
Key exclusion criteria (10 listed)
- Interventional Cohort
- Subjects with benign disease
- Contraindication for surgery and/or general anesthesia.
- Known pregnancy or lactation.
- Subjects receiving prophylactic stoma formation during index surgery (to be confirmed intraoperatively)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| xBar™ SystemDevice: The xBar™ device functions by integrating a sensing electrode array into a standard surgical drain, thereby enabling monitoring without altering standard surgical protocols Description: The Exero Medical xBar™ System is designed to provide continuous postoperative monitoring of gastrointestinal (GI) anastomoses to support the early identification of anastomotic leaks. The device functions by integrating a sensing electrode array into a standard surgical drain, thereby enabling monitoring without altering standard surgical protocols. | Device | Interventional Cohort |
Primary outcome
Primary Effectiveness Endpoint-Demonstrate non-inferiority between the study interventional and historical cohorts
Time frame: At the time points of 30 and 90 days following index surgery
Non-inferiority of the mean Modified Comprehensive Complication Index (MCCI) of the modified intent-to-treat (mITT) population at 30 days following the index surgery, compared with the MCCI of the matched historical cohort.
Primary Safety Endpoint - No Unexpected Serious Adverse Device Events within the Intent to Treat population during the study period ( up to 365 days following index surgery)
Time frame: from the date of index surgery up to 365 days following the index surgery
Lack of unanticipated serious adverse events related to the xBar system or xBar procedure during the study period ( up to 365 days from the index surgery)
3 secondary outcomes
Number of Stoma-Free patients during the study follow up
Time frame: Time points 30 days, 90 days, 6 months and 12 months following the index surgery
Sensitivity and specificity of xBar outcome
Time frame: As from Visit 0 (Day of Surgery -drain placement) through the discharge visits (drain removal as per routine practice), anticipated average 3 days.
1. Comparison of MCCI Comorbidity Index (between study cohorts) 2. Number of Stome-Free patients during the study follow up 3. Sensitivity and specificity of xBar outcome
Time frame: At timepoints of 30, 90 ,180 and 365 days following the index surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ruth Stone contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing xBar™ System in people with Colorectal Cancer, run by Exero Medical Ltd. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilana Fishman (+972547545065, ilana.fishman@exeromedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint-Demonstrate non-inferiority between the study interventional and historical cohorts (time frame: At the time points of 30 and 90 days following index surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.