Colorectal SurgeryCOLO-BTNCT05826743
Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy
A study testing COLO BT™ and Stoma Creation in people with Colorectal Surgery and Colorectal Cancer, run by JSR Medical Co., Ltd. at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the Colorectal Balloon Tube (hereinafter referred to as COLO-BT™) device, a single use, temporary intraluminal bypass device, intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic) Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Surgery, Colorectal Cancer, Rectal/Anal
- What is being tested?
- COLO BT™ and Stoma Creation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Dec 2023to 15 Mar 2028
- 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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient must meet all study Inclusion Criteria as outlined below:
- Adult males or females, 19-80 years of age, with signed informed consent
- Subject whose anastomosis is expected to be located above 4cm from the anus, and at or below 15cm from the anus. (4cm < inclusion target ≤ 15cm from the anus).
- ③ Patient must meet all other inclusion criteria to be eligible. While not required, if one or more of the following six risk factors for postoperative anastomotic leakage[6,7,8] is true, the patient will be considered a high-risk subject:
- Male
- Those with a body mass index of 30 or higher
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- Current smoker
- Those who are on medication for diabetes
- Those with clinical stage III or higher malignant tumors
- Those who received chemo/radiation therapy before surgery
- ④ Those who are willing and able to participate in this clinical study, provide Informed Consent, and are willing to comply with the study procedures and follow up evaluations
- ⑤ Those who have willingness to undertake blood transfusion if required.
Who cannot join
- Patients meeting any of the following Exclusion Criteria will not be eligible to participate in the study:
- Women who are pregnant or breastfeeding
- Those who receive emergency surgery
- A person who is expected to need intensive medical care after the surgery due to a serious medical condition, with one or more of the following seven factors being true:
- Patients with abnormal bone marrow function (those with hemoglobin less than 7g/dl, leukocyte count less than 4000/mm3, or platelet count less than 100,000/mm3 even after preoperative corrections)
- Patients with severe liver damage or cirrhosis (those whose AST/ALT levels are more than three times the normal range or those diagnosed with cirrhosis)
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- Those with abnormal renal function (those who are on hemodialysis or who have a blood creatinine level of 2.0mg/dl or more before the surgery)
- Those who have undergone cardiac or cerebrovascular stent procedure within the last 6 months
- Those who have been diagnosed with pulmonary tuberculosis within the last 6 months or are undergoing drug treatment for pulmonary tuberculosis
- Those who continuously administer steroids of 20mg/day or more within 30 days before the surgery
- Patients with ASA (American Society of Anesthesiologists) score of 3 are evaluated by the investigator who determines whether or not patients with ASA score of 3 should be enrolled from the patient safety standpoint. Patients with ASA score higher than 3 are excluded from this study.
- Patients who are required to undergo re-intervention to treat the anastomosis following intraoperative positive air leak test (However, patients who underwent complete reconstruction of the anastomosis in the presence of a positive air test, which therefore has made their risk of leak similar to those patients with a negative air leak test.)
- Patients who are immune suppressed
- Patients with severe diverticulosis
- Patients with other colonic wall abnormalities in the likely area of the Outer Balloon and BT BAND application who may be at increased risk for device perforation or migration.
- A person who has difficulty in mobility or is unable to communicate in general due to a psychiatric/neurologic disorder falling under one or more of the following:
- Those diagnosed with dementia or Alzheimer's disease.
- Those who have been diagnosed with schizophrenia or depression or are taking drugs due to this.
- A person who has been diagnosed with disability due to intellectual disability.
- Patients with intestinal perforation, abscess in the pelvis, or severe inflammation in the pelvis.
- Those who have a history of undergoing major surgeries (major bowel resection/major gastrectomy, major hepatectomy) through laparotomy and are likely to have serious adhesions that may affect this surgery.
- A patient who underwent a preoperative chemotherapy, but the anastomosis is expected to be located very close to the anus or in the anal canal, thus with a very high risk for complications of the anastomosis, or a patient whom the bowel function is expected to decrease significantly in the future.
- Patients who had pre-operative radiotherapy should be excluded.
- Patients with inflammatory bowel diseases such as ulcerative colitis, Crohn's disease, intestinal tuberculosis, or autoimmune diseases such as Bechet's disease.
- Those who do not consent in writing to the study.
- Experienced blood loss (>750 cc) within 6 weeks before randomization.
- Transfusion during surgery.
- Any new sign of ischemia within 6 weeks before randomization.
- Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel all due to carcinomatosis within 6 weeks before randomization.
- Known hypersensitivity or allergy to any of the components required for the procedure.
- Exclusion criteria not specified above, but the patient is determined to be unsuitable for participation in this clinical study at the judgment of the researcher.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Jacobs School of Medicine & Biomedical Sciences, State University of New York at Buffalo
Buffalo, New York, 14203
Kim, 716-480-7627, kbrunton@buffalo.edu
- Recruiting
PennState Health - Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Damaris, 717-531-0003 ext. 268789, dromberger1@pennstatehealth.psu.edu
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Hector, 915-271-7135, hector.garcia-chavez@bcm.edu
About this study
Official title: Safety and Effectiveness Evaluations of the COLO-BT™ (Colorectal Balloon Tube) as an Alternative Treatment to the Temporary Ileostomy Following Proctectomy
The purpose of this study is to evaluate the Colorectal Balloon Tube (hereinafter referred to as COLO-BT™) device, a single use, temporary intraluminal bypass device, intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic)
Read the detailed description
A primary diverting stoma is widely used by surgeons in order to bypass low rectal anastomosis and reduce morbidity associated with anastomotic leaks. Typically, a stoma is created for all high-risk patients which mean that many patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit.
COLO BT™ is a local, temporary bypass device that provides protection of the anastomosis and safely postpones stoma. COLO BT™ is designed to avoid stoma creation in all patients except those patients whose anastomoses have not healed after surgery, allowing the others to return to normal activity more quickly and safely.
- Conditions
- Colorectal Surgery, Colorectal Cancer, Rectal/Anal, Ileostomy - Stoma, Anastomotic Leakage
- Being tested
- COLO BT™, Stoma Creation
- Keywords
- Colorectal Surgery, Colorectal Cancer, Stoma, ileostomy, Anastomotic leakage
- Medical subject headings
- Colorectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COLO BT™Device
Also called COLO BT
A removable, temporary intraluminal bypass device designed to safely postpone the creation of a protective stoma after surgery for only patients who need it (do not have a healed anastomosis)
Stoma CreationOther
Protective ileostomy
| Study group | Role | What they receive |
|---|---|---|
| COLO BT™ | Experimental | Patients receive COLO BT™ during colorectal surgery. Receives: Device: COLO BT™ |
| Standard of Care | Active comparator | Patients receive the standard of care, a protective stoma, during colorectal surgery. Receives: Other: Stoma Creation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Success Case(Avoidance of ostomy)
Study Success Case" is defined as a case which has met both the "Clinical Success" and "Technical Success" requirements throughout the 24 weeks (6 Months) monitoring period, following the initial surgical treatment with COLO-BT™ or temporary ileostomy
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start4 Dec 2023
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JSR Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark A Falvo, MD, Principal investigator, Jacobs School of Medicine & Biomedical Sciences, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826743
- Sponsor's protocol ID
- JSR CB
- Acronym
- COLO-BT
- Status last verified
- Aug 2026
- First submitted
- 12 Apr 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Evaluations of the COLO-BT™ (Colorectal Balloon Tube) as an Alternative Treatment to the Temporary Ileostomy Following Proctectomy
- ClinicalTrials.gov ID
- NCT05826743
- Acronym / sponsor ID
- COLO-BT / JSR CB
- Conditions
- Colorectal Surgery, Colorectal Cancer, Rectal/Anal, Ileostomy - Stoma, Anastomotic Leakage
- Keywords
- Colorectal Surgery, Colorectal Cancer, Stoma, ileostomy, Anastomotic leakage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- JSR Medical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 24 Apr 2023 (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.
The purpose of this study is to evaluate the Colorectal Balloon Tube (hereinafter referred to as COLO-BT™) device, a single use, temporary intraluminal bypass device, intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic)
Detailed description
A primary diverting stoma is widely used by surgeons in order to bypass low rectal anastomosis and reduce morbidity associated with anastomotic leaks. Typically, a stoma is created for all high-risk patients which mean that many patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit.
COLO BT™ is a local, temporary bypass device that provides protection of the anastomosis and safely postpones stoma. COLO BT™ is designed to avoid stoma creation in all patients except those patients whose anastomoses have not healed after surgery, allowing the others to return to normal activity more quickly and safely.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COLO BT™ | Experimental | Device: COLO BT™Patients receive COLO BT™ during colorectal surgery. |
| Standard of Care | Active comparator | Other: Stoma CreationPatients receive the standard of care, a protective stoma, during colorectal surgery. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adult males or females, 19-80 years of age, with signed informed consent
- ③ Patient must meet all other inclusion criteria to be eligible. While not required, if one or more of the following six risk factors for postoperative anastomotic leakage[6,7,8] is true, the patient will be considered a high-risk subject:
- ④ Those who are willing and able to participate in this clinical study, provide Informed Consent, and are willing to comply with the study procedures and follow up evaluations
- ⑤ Those who have willingness to undertake blood transfusion if required.
Key exclusion criteria (31 listed)
- Patients meeting any of the following Exclusion Criteria will not be eligible to participate in the study:
- Women who are pregnant or breastfeeding
- Those who receive emergency surgery
- A person who is expected to need intensive medical care after the surgery due to a serious medical condition, with one or more of the following seven factors being true:
- A person who has difficulty in mobility or is unable to communicate in general due to a psychiatric/neurologic disorder falling under one or more of the following:
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 |
|---|---|---|
| COLO BT™Also: COLO BTA removable, temporary intraluminal bypass device designed to safely postpone the creation of a protective stoma after surgery for only patients who need it (do not have a healed anastomosis) | Device | COLO BT™ |
| Stoma CreationProtective ileostomy | Other | Standard of Care |
Primary outcome
Study Success Case(Avoidance of ostomy)
Time frame: 24 Weeks
Study Success Case" is defined as a case which has met both the "Clinical Success" and "Technical Success" requirements throughout the 24 weeks (6 Months) monitoring period, following the initial surgical treatment with COLO-BT™ or temporary ileostomy
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 5 Aug 2026.
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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.
Mark A Falvo, MD principal investigator
Jacobs School of Medicine & Biomedical Sciences, State University of New York at Buffalo
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COLO BT™ and Stoma Creation in people with Colorectal Surgery and Colorectal Cancer, run by JSR Medical Co., Ltd. at 3 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 12 inclusion and 31 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 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Kim (+82-10-9345-1058, jakehykim@jsrmed.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Success Case(Avoidance of ostomy) (time frame: 24 Weeks). 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 5 Aug 2026.