Anastomosis, LeakingNCT07490080
Study With Dehisgel Used in Adult Patients Undergoing Colorectal Anastomosis
An observational study of Anastomosis, Leaking, run by Contipro Pharma a.s. at 1 site in Czechia.
Trial summary
A two-phase, multicenter, open-label, "first-in-human" prospective study evaluating the product's safety and efficacy in a pivotal phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomosis, Leaking
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 23 Oct 2024to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients included in the study underwent elective rectal resection with colorectal anastomosis due to rectal cancer.
Who may be able to join
- Age ≥ 18 years
- Patients with histologically confirmed rectal adenocarcinoma (< 15 cm from the anal margin) following rectal resection with colorectal anastomosis
- Patients with or without neoadjuvant therapy
- Patients willing and able to provide written informed consent
- Patients able to communicate effectively with the investigator in the local language and to understand and comply with the study requirements.
Who cannot join
- Age < 18 years
- Pregnant or breastfeeding women
- Patients in the terminal stage of life
- Subjects with known hypersensitivity or allergy to any component of the investigational product or to the administered antibiotics
- Acute surgery
- Preventive ostomy
- Other malignancies
- Incomplete data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-centre, Open-label, First-in-man Study With Dehisgel Used in Adult Patients Undergoing Colorectal Anastomosis Due to Rectal Cancer.
A two-phase, multicenter, open-label, "first-in-human" prospective study evaluating the product's safety and efficacy in a pivotal phase.
- Conditions
- Anastomosis, Leaking
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of anastomotic leak
(Grade B, C according to the International Study Group of Rectal Cancer)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start23 Oct 2024
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Why it stopped: safety was ok, but efficacy was considered too low - it was decided not to continue woth this study design
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomosis, LeakingStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contipro Pharma a.s.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490080
- Sponsor's protocol ID
- PT-DEH-1_02-24
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 24 Mar 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 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre, Open-label, First-in-man Study With Dehisgel Used in Adult Patients Undergoing Colorectal Anastomosis Due to Rectal Cancer.
- ClinicalTrials.gov ID
- NCT07490080
- Acronym / sponsor ID
- PT-DEH-1_02-24
- Conditions
- Anastomosis, Leaking
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: safety was ok, but efficacy was considered too low - it was decided not to continue woth this study design
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Contipro Pharma a.s.University, hospital or other
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 24 Mar 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.
A two-phase, multicenter, open-label, "first-in-human" prospective study evaluating the product's safety and efficacy in a pivotal phase.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients included in the study underwent elective rectal resection with colorectal anastomosis due to rectal cancer.
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Patients with histologically confirmed rectal adenocarcinoma (< 15 cm from the anal margin) following rectal resection with colorectal anastomosis
- Patients with or without neoadjuvant therapy
- Patients willing and able to provide written informed consent
- Patients able to communicate effectively with the investigator in the local language and to understand and comply with the study requirements.
Key exclusion criteria (8 listed)
- Age < 18 years
- Pregnant or breastfeeding women
- Patients in the terminal stage of life
- Subjects with known hypersensitivity or allergy to any component of the investigational product or to the administered antibiotics
- Acute surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of anastomotic leak
Time frame: 30 days
(Grade B, C according to the International Study Group of Rectal Cancer)
Results and safety
The study was stopped early (reason given: safety was ok, but efficacy was considered too low - it was decided not to continue woth this study design). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anastomosis, Leaking, run by Contipro Pharma a.s. at 1 site in Czechia.
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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 24 Mar 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 Czechia. 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?
The study was stopped early (reason given: safety was ok, but efficacy was considered too low - it was decided not to continue woth this study design). Results are not available in the source record.
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?
Incidence of anastomotic leak (time frame: 30 days). 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 24 Mar 2026.