Disposable Intestinal Isolation and Protection DeviceNCT07825129
Disposable Intestinal Isolation and Protection Device for Patients With Rectal and Lower Sigmoid Colon Tumors Undergoing Laparoscopic AR/LAR Surgery
A study testing According to the different structures, it is divided into TPYRIB type and TPYRIS type. According to the different outer dimensions of the pocket and the outer sleeve, it is divided into two specificat and sterile gauze in people with Disposable Intestinal Isolation and Protection Device, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
The small intestine is the main organ in the abdominal cavity, approximately 4 to 5 meters in length, occupying most of the middle and lower abdomen. Due to the long mesentery of the small intestine, it is in a free state and has a high degree of mobility. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Disposable Intestinal Isolation and Protection Device
- What is being tested?
- According to the different structures, it is divided into TPYRIB type and TPYRIS type. According to the different outer dimensions of the pocket and the outer sleeve, it is divided into two specificat and sterile gauze
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2026to 31 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥22 years old, gender not limited.
- Patients with rectal and lower sigmoid colon tumors who underwent laparoscopic AR/LAR surgery.
- Patients with a BMI of ≥25 agreed to participate in this trial and signed the informed consent form.
- The distance between the tumor and the anus as measured by enteroscopy should not exceed 20cm.
Who cannot join
- Female patients who have participated in or are currently participating in other clinical studies within 3 months before the operation,
- Have acute infections,
- Severe small intestinal adhesions or severe edema,
- Severe abdominal adhesions,
- Are known to be allergic to silicone,
- Have a history of severe allergies or severe immune deficiencies,
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- Are pregnant or lactating.
- The researcher judged that the patient had poor compliance and was unable to complete the study as required.
- Due to cognitive impairment, I am unable to understand the researcher's introduction or explanation of this trial.
- Those who have undergone previous intestinal or pelvic surgery.
- Tissues removed during surgery, including those with sharp or pointed edges, such as broken bone fragments, are not suitable for use with this instrument.
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
Beijing Friendship Hospital, Capital medical University
Beijing, Xicheng Dis, 100050
About this study
Official title: A Randomized, Controlled, Open Multicenter Clinical Study on the Efficacy and Safety of a Disposable Intestinal Isolation Protective Device in Patients With Rectal and Lower Sigmoid Colon Tumors Undergoing Laparoscopic AR/LAR Surgery
The small intestine is the main organ in the abdominal cavity, approximately 4 to 5 meters in length, occupying most of the middle and lower abdomen. Due to the long mesentery of the small intestine, it is in a free state and has a high degree of mobility. When performing abdominal surgery, especially lower abdominal surgery, the freedom and slippability of the small intestine often affect the exposure of the surgical site and the operating field of vision. Lower abdominal surgery generally includes colorectal surgery, gynecological surgery, urological surgery, etc. At present, in clinical practice, open surgeries, including minimally invasive laparoscopic manual surgeries, mainly involve significantly adjusting the patient's position to slide the small intestine into the surgical field, or simply surrounding and covering the small intestine with gauze pads and assisting in pulling with the help of assistants. However, the results are not satisfactory, especially for obese patients.
In the current clinical practice of performing middle and lower abdominal surgeries, especially laparoscopic surgeries, a device superior to gauze isolation pads is needed. It can separate the small intestine from the surgical site to expose the surgical area, facilitating doctors to perform manual operations calmly and reducing the operation time and complications. Avoid the special position with the head low and the feet high, which may increase the risk of restricted cardiac and respiratory functions in patients and reduce the impact on surgical anesthesia.
To collect more data on the efficacy and safety of this product for abdominal surgery, it is planned to conduct this post-market clinical study. This clinical study will adhere to the Good Clinical Practice for Medical Devices and relevant laws and regulations, and strictly implement the clinical research protocol.
- Being tested
- According to the different structures, it is divided into TPYRIB type and TPYRIS type. According to the different outer dimensions of the pocket and the outer sleeve, it is divided into two specificat, sterile gauze
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
According to the different structures, it is divided into TPYRIB type and TPYRIS type. According to the different outer dimensions of the pocket and the outer sleeve, it is divided into two specificatDevice
The TPYRIB type is composed of a separator bag, a binding film, a tightening sleeve, a push rod handle, a push rod, an outer sleeve, an outer sleeve handle, a hook and a spring clip, a puncture needle, a fixing plate and a pull hook. The TPYRIS type is composed of an outer sleeve cap, a spacer bag, an expansion ring, a pull rod, a push rod handle, a push rod, an outer sleeve, an outer sleeve handle, a hook and a retaining ring, and a fixed block.
sterile gauzeDevice
sterile gauze
| Study group | Role | What they receive |
|---|---|---|
| Conventional gauze group | Active comparator | Conventional surgery method Receives: Device: sterile gauze |
| Intestinal devrce group | Experimental | Operate using specialized equipment Receives: Device: According to the different structures, it is divided into TPYRIB type and TPYRIS type. According to the different outer dimensions of the pocket and the outer sleeve, it is divided into two specificat |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main efficacy evaluation index: During the surgery.
Evaluation method: Treatment group: The time from opening and starting to use the disposable small intestinal isolation protection device to completing the retrieval of the disposable small intestinal isolation bag. Control group: From the first time the gauze is opened and used to the time when the last piece of gauze is retrieved.
Measured: The subject visit windows are set as follows: Screening period: -7 days, i.e., within 7 days before the surgery Treatment period: 0 days, on the day of the surgery Observation period: 1-7 days after the surgery (including 7 days after the surgery) Follow
Secondary outcomes (3)
Evaluation of equipment usage
On the day of the surgery (within 24 hours), the researchers evaluated the ease of use of the product during open surgery and laparoscopic surgery, whether there was accidental injury to surrounding organs, whether the surgical field was satisfactory, and whether multiple isolations were required. Use a 5-point scale (0 for light, 5 for heavy, in ascending order).
Measured: From the time of enrollment until the end of the 3-month treatment period.
Surgical Position Record
On the day of surgery (within 24h), the researcher adjusted the body position according to the intraoperative requirements, which was supine, within 15° (0-15° including 15°), 15-30 ° (15°-30° including 30°), and more than 30° (greater than 30°).
Measured: From the time of enrollment until the end of the 3-month treatment period.
First exhaust time
Starting from the day of the surgery, record the duration (eg. 12h-24 m, HH-MM) of the first time the patient passed gas after the surgery.
Measured: From the time of enrollment until the end of the 3-month treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start27 May 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disposable Intestinal Isolation and Protection DeviceStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongtao Zhang, Beijing Friendship Hospital
- Investigators
- ZHONGTAO ZHANG, Doctor, Study chair, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825129
- Sponsor's protocol ID
- BFH-XCGL
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2026
- Last updated
- 17 Sep 2026
- 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open Multicenter Clinical Study on the Efficacy and Safety of a Disposable Intestinal Isolation Protective Device in Patients With Rectal and Lower Sigmoid Colon Tumors Undergoing Laparoscopic AR/LAR Surgery
- ClinicalTrials.gov ID
- NCT07825129
- Acronym / sponsor ID
- BFH-XCGL
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 27 May 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Sep 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.
The small intestine is the main organ in the abdominal cavity, approximately 4 to 5 meters in length, occupying most of the middle and lower abdomen. Due to the long mesentery of the small intestine, it is in a free state and has a high degree of mobility. When performing abdominal surgery, especially lower abdominal surgery, the freedom and slippability of the small intestine often affect the exposure of the surgical site and the operating field of vision. Lower abdominal surgery generally includes colorectal surgery, gynecological surgery, urological surgery, etc. At present, in clinical practice, open surgeries, including minimally invasive laparoscopic manual surgeries, mainly involve significantly adjusting the patient's position to slide the small intestine into the surgical field, or simply surrounding and covering the small intestine with gauze pads and assisting in pulling with the help of assistants. However, the results are not satisfactory, especially for obese patients.
In the current clinical practice of performing middle and lower abdominal surgeries, especially laparoscopic surgeries, a device superior to gauze isolation pads is needed. It can separate the small intestine from the surgical site to expose the surgical area, facilitating doctors to perform manual operations calmly and reducing the operation time and complications. Avoid the special position with the head low and the feet high, which may increase the risk of restricted cardiac and respiratory functions in patients and reduce the impact on surgical anesthesia.
To collect more data on the efficacy and safety of this product for abdominal surgery, it is planned to conduct this post-market clinical study. This clinical study will adhere to the Good Clinical Practice for Medical Devices and relevant laws and regulations, and strictly implement the clinical research protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional gauze group | Active comparator | Device: sterile gauzeConventional surgery method |
| Intestinal devrce group | Experimental | Device: According to the different structures, it is divided into TPYRIB type and TPYRIS type. According to the different outer dimensions of the pocket and the outer sleeve, it is divided into two specificatOperate using specialized equipment |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥22 years old, gender not limited.
- Patients with rectal and lower sigmoid colon tumors who underwent laparoscopic AR/LAR surgery.
- Patients with a BMI of ≥25 agreed to participate in this trial and signed the informed consent form.
- The distance between the tumor and the anus as measured by enteroscopy should not exceed 20cm.
Key exclusion criteria (11 listed)
- Female patients who have participated in or are currently participating in other clinical studies within 3 months before the operation,
- Have acute infections,
- Severe small intestinal adhesions or severe edema,
- Severe abdominal adhesions,
- Are known to be allergic to silicone,
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 |
|---|---|---|
| According to the different structures, it is divided into TPYRIB type and TPYRIS type. According to the different outer dimensions of the pocket and the outer sleeve, it is divided into two specificatThe TPYRIB type is composed of a separator bag, a binding film, a tightening sleeve, a push rod handle, a push rod, an outer sleeve, an outer sleeve handle, a hook and a spring clip, a puncture needle, a fixing plate and a pull hook. The TPYRIS type is composed of an outer sleeve cap, a spacer bag, an expansion ring, a pull rod, a push rod handle, a push rod, an outer sleeve, an outer sleeve handle, a hook and a retaining ring, and a fixed block. | Device | Intestinal devrce group |
| sterile gauzesterile gauze | Device | Conventional gauze group |
Primary outcome
The main efficacy evaluation index: During the surgery.
Time frame: The subject visit windows are set as follows: Screening period: -7 days, i.e., within 7 days before the surgery Treatment period: 0 days, on the day of the surgery Observation period: 1-7 days after the surgery (including 7 days after the surgery) Follow
Evaluation method: Treatment group: The time from opening and starting to use the disposable small intestinal isolation protection device to completing the retrieval of the disposable small intestinal isolation bag. Control group: From the first time the gauze is opened and used to the time when the last piece of gauze is retrieved.
3 secondary outcomes
Evaluation of equipment usage
Time frame: From the time of enrollment until the end of the 3-month treatment period.
Surgical Position Record
Time frame: From the time of enrollment until the end of the 3-month treatment period.
First exhaust time
Time frame: From the time of enrollment until the end of the 3-month treatment period.
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 17 Sep 2026.
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.
ZHONGTAO ZHANG, Doctor study chair
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing According to the different structures, it is divided into TPYRIB type and TPYRIS type. According to the different outer dimensions of the pocket and the outer sleeve, it is divided into two specificat and sterile gauze in people with Disposable Intestinal Isolation and Protection Device, run by Beijing Friendship Hospital 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 4 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 17 Sep 2026. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main efficacy evaluation index: During the surgery. (time frame: The subject visit windows are set as follows: Screening period: -7 days, i.e., within 7 days before the surgery Treatment period: 0 days, on the day of the surgery Observation period: 1-7 days after the surgery (including 7 days after the surgery) Follow). 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 17 Sep 2026.