Colon AnastomosisNCT07100886
Seal-G/ Seal-G MIST Long-Term Follow-up PMCF (Continue) Study
An observational study of Colon Anastomosis, run by Advanced Medical Solutions Ltd..
Trial summary
Postoperative complications following colon anastomosis surgery, such as adhesions, stenosis, stricture and obstruction, can significantly impact patient outcomes. The use of surgical sealants has been proposed as a means to mitigate anastomotic complications by providing a protective barrier over the anastomosis… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colon Anastomosis
- What is being tested?
- long-term follow up visit
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- 4 Aug 2025to 30 Jan 2026
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For the Retrospective Treatment Group, 3 out of the 8 sites participated in the previous PMCF study (#DLG-072-06), will be included with a total of 104 patients who received the Seal-G / Seal-G MIST surgical sealant during colon anastomosis surgery 2-4 years ago (during 2021-2023). The following sites were selected due to relatively large number of participants in the previous study and according to their ability to comply with the current study procedures. For the Retrospective Control group, screening will be performed at each site, for a matching number of subjects from a comparable population (i.e age; BMI; surgery procedure (2-4 years ago); etc.) that did not receive the sealant treatment.
Who may be able to join
- Treatment Group: Patients participated and completed all visits in the previous PMCF study (treatment group; #DLG-072-06)
- Control Group: comparable retrospective subjects that meet the same inclusion criteria specified in #DLG-072-06.
- Both Treatment \& Control group:
- Willing to comply with long-term follow-up assessment (including oral consent).
Who cannot join
- Both Treatment \& Control group:
- Patients who are unable or unwilling to complete the phone questionnaire.
- Control group: Subjects that would have been excluded according to the previous PMCF study #DLG-072-06 exclusion criteria.
- Patients with missing or incomplete medical records that prevent retrospective comparison.
- Patients that during the original surgery received any treatment on the anastomosis (sealant/glue) except for the anastomosis closure technique (sutures/staple).
- Original surgery included stoma creation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Long-Term Safety and Efficacy Evaluation of Seal-G and Seal-G MIST Surgical Sealants for Anastomosis Protection in Colon Surgery [PMCF Study Continuation]
Postoperative complications following colon anastomosis surgery, such as adhesions, stenosis, stricture and obstruction, can significantly impact patient outcomes. The use of surgical sealants has been proposed as a means to mitigate anastomotic complications by providing a protective barrier over the anastomosis site, reducing the risk or the severity of anastomotic leak. The previous post-market clinical follow-up (PMCF) study assessed the short-term safety and performance of SEAL-G surgical sealants in preventing anastomotic leaks and early post-operative complications. However, long-term data are needed to establish its sustained safety and effectiveness.
This continuation study aims to evaluate the long-term impact of the SEAL-G/MIST surgical sealant on post-operative complications over 12+ months after surgery. The study will compare complication rates in patients treated with the surgical sealant to a retrospective comparable control group who underwent similar procedures without the sealant.
Read the detailed description
The study is designed as an observational, retrospective-controlled, long-term follow-up, multi-center post-market clinical follow-up (PMCF) study.
For the Retrospective Treatment Group, 3 out of the 8 sites participated in the previous PMCF study (#DLG-072-06), will be included with a total of 104 patients who received the Seal-G / Seal-G MIST surgical sealant during colon anastomosis surgery 2-4 years ago (during 2021-2023). The following sites were selected due to relatively large number of participants in the previous study and according to their ability to comply with the current study procedures.
For the Retrospective Control group, screening will be performed at each site, for a matching number of subjects from a comparable population (i.e age; BMI; surgery procedure (2-4 years ago); etc.) that did not receive the sealant treatment. Phone Questionnaire: Long-term follow-up visit should be performed via Phone call Questionnaire. Patients will be contacted (including Oral informed consent) to assess long-term outcomes relating to the colon anastomosis surgery they underwent 2-4 years ago.
- Incidence of adhesions, stenosis, and obstruction (reported during the Physician questionnaire and confirmed by medical records review where possible).
- Need for reoperation due to complications.
- Use of additional treatments relating to anastomosis complications (e.g., anti-adhesion therapy, bowel obstruction management).
- Conditions
- Colon Anastomosis
- Being tested
- long-term follow up visit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
long-term follow up visitOther
Phone call questionnaire- retrospective treatment arm Phone call questionnaire- retrospective control arm
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Treatment Group | Patients who underwent colectomy and anastomosis coverage with Seal-G / Seal-G MIST as part of the previous PCMF study protocol (#DLG-072-06) Receives: Other: long-term follow up visit | |
| Retrospective Control Group | Patients who underwent colon resection with primary anastomosis (SOC) (comparable population) Receives: Other: long-term follow up visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of reoperation due to anastomotic complications
Measured: 1 year post-surgery
Assessment of long-term anastomotic complications (i.e. adhesions, stenosis, stricture, and obstruction)
At least one complication within the 1 year interval
Measured: 1 year post-surgery
Secondary outcomes (4)
The incidence of anastomotic complications (i.e. adhesions, stenosis, stricture, and obstruction)
Measured: 1-4 years post-surgery
The incidence of hospitalization due to anastomotic complications
Measured: 1-4 years post-surgery
The incidence of reoperation due to anastomotic complications
Measured: 1-4 years post surgery
The incidence of anastomotic leaks (Clinical/sub-clinical)
Measured: 30 day post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start4 Aug 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon AnastomosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced Medical Solutions Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100886
- Sponsor's protocol ID
- DLG-072-13
- Status last verified
- Jul 2025
- First submitted
- 28 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Safety and Efficacy Evaluation of Seal-G and Seal-G MIST Surgical Sealants for Anastomosis Protection in Colon Surgery [PMCF Study Continuation]
- ClinicalTrials.gov ID
- NCT07100886
- Acronym / sponsor ID
- DLG-072-13
- Conditions
- Colon Anastomosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Advanced Medical Solutions Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Aug 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 3 Aug 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.
Postoperative complications following colon anastomosis surgery, such as adhesions, stenosis, stricture and obstruction, can significantly impact patient outcomes. The use of surgical sealants has been proposed as a means to mitigate anastomotic complications by providing a protective barrier over the anastomosis site, reducing the risk or the severity of anastomotic leak. The previous post-market clinical follow-up (PMCF) study assessed the short-term safety and performance of SEAL-G surgical sealants in preventing anastomotic leaks and early post-operative complications. However, long-term data are needed to establish its sustained safety and effectiveness.
This continuation study aims to evaluate the long-term impact of the SEAL-G/MIST surgical sealant on post-operative complications over 12+ months after surgery. The study will compare complication rates in patients treated with the surgical sealant to a retrospective comparable control group who underwent similar procedures without the sealant.
Detailed description
The study is designed as an observational, retrospective-controlled, long-term follow-up, multi-center post-market clinical follow-up (PMCF) study.
For the Retrospective Treatment Group, 3 out of the 8 sites participated in the previous PMCF study (#DLG-072-06), will be included with a total of 104 patients who received the Seal-G / Seal-G MIST surgical sealant during colon anastomosis surgery 2-4 years ago (during 2021-2023). The following sites were selected due to relatively large number of participants in the previous study and according to their ability to comply with the current study procedures.
For the Retrospective Control group, screening will be performed at each site, for a matching number of subjects from a comparable population (i.e age; BMI; surgery procedure (2-4 years ago); etc.) that did not receive the sealant treatment. Phone Questionnaire: Long-term follow-up visit should be performed via Phone call Questionnaire. Patients will be contacted (including Oral informed consent) to assess long-term outcomes relating to the colon anastomosis surgery they underwent 2-4 years ago.
- Incidence of adhesions, stenosis, and obstruction (reported during the Physician questionnaire and confirmed by medical records review where possible).
- Need for reoperation due to complications.
- Use of additional treatments relating to anastomosis complications (e.g., anti-adhesion therapy, bowel obstruction management).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Treatment Group | – | Other: long-term follow up visitPatients who underwent colectomy and anastomosis coverage with Seal-G / Seal-G MIST as part of the previous PCMF study protocol (#DLG-072-06) |
| Retrospective Control Group | – | Other: long-term follow up visitPatients who underwent colon resection with primary anastomosis (SOC) (comparable population) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For the Retrospective Treatment Group, 3 out of the 8 sites participated in the previous PMCF study (#DLG-072-06), will be included with a total of 104 patients who received the Seal-G / Seal-G MIST surgical sealant during colon anastomosis surgery 2-4 years ago (during 2021-2023). The following sites were selected due to relatively large number of participants in the previous study and according to their ability to comply with the current study procedures. For the Retrospective Control group, screening will be performed at each site, for a matching number of subjects from a comparable population (i.e age; BMI; surgery procedure (2-4 years ago); etc.) that did not receive the sealant treatment.
Key inclusion criteria (4 listed)
- Treatment Group: Patients participated and completed all visits in the previous PMCF study (treatment group; #DLG-072-06)
- Control Group: comparable retrospective subjects that meet the same inclusion criteria specified in #DLG-072-06.
- Both Treatment \& Control group:
- Willing to comply with long-term follow-up assessment (including oral consent).
Key exclusion criteria (6 listed)
- Both Treatment \& Control group:
- Patients who are unable or unwilling to complete the phone questionnaire.
- Control group: Subjects that would have been excluded according to the previous PMCF study #DLG-072-06 exclusion criteria.
- Patients with missing or incomplete medical records that prevent retrospective comparison.
- Patients that during the original surgery received any treatment on the anastomosis (sealant/glue) except for the anastomosis closure technique (sutures/staple).
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 |
|---|---|---|
| long-term follow up visitPhone call questionnaire- retrospective treatment arm Phone call questionnaire- retrospective control arm | Other | Retrospective Control Group, Retrospective Treatment Group |
Primary outcome
Rate of reoperation due to anastomotic complications
Time frame: 1 year post-surgery
Assessment of long-term anastomotic complications (i.e. adhesions, stenosis, stricture, and obstruction)
Time frame: 1 year post-surgery
At least one complication within the 1 year interval
4 secondary outcomes
The incidence of anastomotic complications (i.e. adhesions, stenosis, stricture, and obstruction)
Time frame: 1-4 years post-surgery
The incidence of hospitalization due to anastomotic complications
Time frame: 1-4 years post-surgery
The incidence of reoperation due to anastomotic complications
Time frame: 1-4 years post surgery
The incidence of anastomotic leaks (Clinical/sub-clinical)
Time frame: 30 day post 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 3 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Anastomosis, run by Advanced Medical Solutions Ltd..
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 6 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: opening soon, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Naama Giwnewer, Clinical Manager (+972506979691, naamag@admedsol.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of reoperation due to anastomotic complications (time frame: 1 year post-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 3 Aug 2025.