Rectal Cancer Stage IIIPhase 3NCT06968221
Bovine Reinforcement in Stomach, Colorectal and Lung Operation
A Phase 3 study testing Bioabsorbable Staple Line Reinforcemen in people with Rectal Cancer Stage III and Lung Cancer Stage III, run by Shanghai Cingularbio Co. Ltd at 1 site in China.
Trial summary
The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of stomach,colorectal and lung anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced techniques with respect to the incidence of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer Stage III, Lung Cancer Stage III
- What is being tested?
- Bioabsorbable Staple Line Reinforcemen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 31 Oct 2026
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who will undergo operation with stapled stomach, colorectal anastomosis with or without reinforcement
- Subjects willing to accept informed consent and willing to attend the follow up
Who cannot join
- Subjects who have significant intraoperative hypotension or cardiac events.
- Subjects with collagen vascular disease, coagulopathy, significant renal or hepatic dysfunction (creatinine >1.6 or liver enzymes > 50% upper limit of normal values).
- Subjects have uncontrolled intra-abdominal infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji hospital affiliated to Shanghai jiaotong Uni school of medicine
Shanghai
study director
About this study
Official title: A Study on the Safety and Efficacy of Using Cingular Bovine Pericardium Anastomosis Reinforcement Membrane for Tissue Reinforcement and Hemostasis at Anastomotic Sites
The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of stomach,colorectal and lung anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced techniques with respect to the incidence of postoperative hemorrage rate, anastomotic leakage, if applicable.
Read the detailed description
This is a randomized prospective trial that compares the use of Cingular Bioabsorbable Staple Line Reinforcement to standard stapling techniques in tissue resections. The potential exists to utilize staple line reinforcement as a means of lowering the rate of post-operative hemorrage rate, anastomotic leakage.
- Conditions
- Rectal Cancer Stage III, Lung Cancer Stage III
- Being tested
- Bioabsorbable Staple Line Reinforcemen
- Medical subject headings
- Rectal Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioabsorbable Staple Line ReinforcemenDevice
cingular Bioabsorbable Staple Line Reinforcement
| Study group | Role | What they receive |
|---|---|---|
| Bioabsorbable Staple Line Reinforcement configured for circular staplers | Experimental | stomach, Colorectal and lung anastomotic staple line reinforcement with Bioabsorbable Staple Line Reinforcement configured for circular staple Receives: Device: Bioabsorbable Staple Line Reinforcemen |
| anastomotic staple line without reinforcement | Active comparator | stomach, colorectal and lung anastomotic staple line without reinforcement Receives: Device: Bioabsorbable Staple Line Reinforcemen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Who Experience a hemorrage
The primary endpoint for the study is the proportion of subjects who experience a hemorrage through 10 min post procedure.
Measured: 10 min
Secondary outcomes (1)
Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak
The primary endpoint for the study is the proportion of subjects who experience a clinical and/or radiologic anastomotic leak through 1-3 months post procedure.
Measured: 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 May 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer Stage IIIStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- with a bioabsorbable staple line reinforcement material compared with standard non-reinforced material
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Cingularbio Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RenJi Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968221
- Sponsor's protocol ID
- BSLR-2024-01
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Safety and Efficacy of Using Cingular Bovine Pericardium Anastomosis Reinforcement Membrane for Tissue Reinforcement and Hemostasis at Anastomotic Sites
- ClinicalTrials.gov ID
- NCT06968221
- Acronym / sponsor ID
- BSLR-2024-01
- Conditions
- Rectal Cancer Stage III, Lung Cancer Stage III
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Shanghai Cingularbio Co. LtdIndustry (pharma, biotech, devices)
- Collaborators
- RenJi Hospital
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 13 May 2025 (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 primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of stomach,colorectal and lung anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced techniques with respect to the incidence of postoperative hemorrage rate, anastomotic leakage, if applicable.
Detailed description
This is a randomized prospective trial that compares the use of Cingular Bioabsorbable Staple Line Reinforcement to standard stapling techniques in tissue resections. The potential exists to utilize staple line reinforcement as a means of lowering the rate of post-operative hemorrage rate, anastomotic leakage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- with a bioabsorbable staple line reinforcement material compared with standard non-reinforced material
| Arm | Type | Receives |
|---|---|---|
| Bioabsorbable Staple Line Reinforcement configured for circular staplers | Experimental | Device: Bioabsorbable Staple Line Reinforcemenstomach, Colorectal and lung anastomotic staple line reinforcement with Bioabsorbable Staple Line Reinforcement configured for circular staple |
| anastomotic staple line without reinforcement | Active comparator | Device: Bioabsorbable Staple Line Reinforcemenstomach, colorectal and lung anastomotic staple line without reinforcement |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who will undergo operation with stapled stomach, colorectal anastomosis with or without reinforcement
- Subjects willing to accept informed consent and willing to attend the follow up
Key exclusion criteria (3 listed)
- Subjects who have significant intraoperative hypotension or cardiac events.
- Subjects with collagen vascular disease, coagulopathy, significant renal or hepatic dysfunction (creatinine >1.6 or liver enzymes > 50% upper limit of normal values).
- Subjects have uncontrolled intra-abdominal infection
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 |
|---|---|---|
| Bioabsorbable Staple Line Reinforcemencingular Bioabsorbable Staple Line Reinforcement | Device | Bioabsorbable Staple Line Reinforcement configured for circular staplers, anastomotic staple line without reinforcement |
Primary outcome
Proportion of Subjects Who Experience a hemorrage
Time frame: 10 min
The primary endpoint for the study is the proportion of subjects who experience a hemorrage through 10 min post procedure.
1 secondary outcome
Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak
Time frame: 1-3 months
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 15 May 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bioabsorbable Staple Line Reinforcemen in people with Rectal Cancer Stage III and Lung Cancer Stage III, run by Shanghai Cingularbio Co. Ltd at 1 site in China.
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 2 inclusion and 3 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 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 study director (02138016387, july_s@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects Who Experience a hemorrage (time frame: 10 min). 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 15 May 2025.