Clinical trial · Interventional
Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar
NCT07337590CI-TRIAL-00114901ASSURErecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Purpose: To evaluate the effect of xBar system utilization on clinical outcomes during recovery following colorectal surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| xBar™ System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interventional Cohort
- description
- 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.
- interventionNames
- Device: xBar™ System
- type
- NO_INTERVENTION
- label
- Historical Control Cohort
- description
- 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.
Primary outcomes (2)
- measure
- Primary Effectiveness Endpoint-Demonstrate non-inferiority between the study interventional and historical cohorts
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: Interventional Cohort 1. Adults (≥21 years) scheduled for elective low anterior resection (by any surgical technique), due to colorectal cancer 2. Expected anastomosis within 10 cm from the anal verge 3. Usage of drain during the surgery (to be confirmed during the surgery) 4. Willing and able to comply with the study follow up and able and agree to provide informed consent. Historical Cohort 1. Adults aged ≥21 years at the time of surgery. 2. Underwent a low anterior resection (LAR) for malignant colorectal disease. 3. 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. Exclusion Criteria: Interventional Cohort 1. Subjects with benign disease 2. Contraindication for surgery and/or general anesthesia. 3. Known pregnancy or lactation. 4. Subjects receiving prophylactic stoma formation during index surgery (to be confirmed intraoperatively) 5. Known electronic devices implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator). 6. Major medical or psychiatric illness or condition, or other factors that may affect general health or ability to adhere to the follow-up schedule. 7. Known allergic reactions to materials used in the components of the xBar system, i.e., silicone, rubber and stainless-steel. 8. 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).
References
Publications (0)
Data not yet available
No reference posted for this study.