RectocelePOP-01NCT04564677
A Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy
An observational study of Rectocele and Enterocele, run by Duomed at 1 site in Belgium.
Trial summary
The purpose of this observational study is to evaluate the clinical outcome of a modified d'Hoore technique for laparoscopic ventral mesh rectopexy in patients with primary rectal prolapse, rectocele and/or enterocele.The goal of the study will be achieved by reporting the peri- and postoperative complications… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Rectocele, Enterocele, Rectal Prolapse
- What is being tested?
- Ifabond (Péters surgical)
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Feb 2021to 31 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy.
Who may be able to join
- Female patients.
- Patient ≥ 18 years of age at study entry.
- Patient and investigator signed and dated the informed consent form prior to the index-procedure.
- Patient with primary rectal prolapse (grades I to V according to the Oxford scale), rectocele and/or enterocele.
Who cannot join
- Patient is unable / unwilling to provide informed consent.
- Patient with recurrent rectal prolapse, rectocele and/or enterocele.
- Patient is unable to comply with the study protocol or proposed follow-up visits.
- Patient has a contra-indication for laparoscopic ventral mesh rectopexy.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Ziekenhuis Oost-Limburg (ZOL)
Genk
Anne Dams, MD, +32 (0)89 32 60 20
About this study
Official title: A Prospective Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy
The purpose of this observational study is to evaluate the clinical outcome of a modified d'Hoore technique for laparoscopic ventral mesh rectopexy in patients with primary rectal prolapse, rectocele and/or enterocele.The goal of the study will be achieved by reporting the peri- and postoperative complications ((serious) adverse events), recurrences and re-interventions. Pre-operative to postoperative changes in pain, functional outcome and quality of life will be evaluated as well.
- Conditions
- Rectocele, Enterocele, Rectal Prolapse
- Being tested
- Ifabond (Péters surgical)
- Medical subject headings
- Rectocele, Hernia, Rectal Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ifabond (Péters surgical)Device
Ifabond (Péters surgical) is a CE-marked synthetic surgical glue for internal and external use. The glue is non-toxic, biocompatible and biodegradable. It is commercially available and can be used for mesh fixation, as tissue adhesive, for sealing of sutured tissue and for hemostasis.
| Study group | Role | What they receive |
|---|---|---|
| Patients eligible for laparoscopic ventral mesh rectopexy | Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy (LVMR) Receives: Device: Ifabond (Péters surgical) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural efficacy - Number of participants with (serious) adverse events
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Measured: During procedure
Procedural efficacy - Conversion rate to laparotomy during the index procedure
Number of conversions to laparotomy during the index procedure
Measured: During procedure
Procedural efficacy - Number of participants with (serious) adverse events
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Measured: At discharge (assessed up to 1 week)
Procedural efficacy - Number of re-interventions
Number of re-interventions
Measured: At discharge (assessed up to 1 week)
Procedural efficacy - Number of participants with (serious) adverse events
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Measured: Follow-up 1: 6 - 10 weeks after the procedure
Procedural efficacy - Number of re-interventions
Number of re-interventions
Measured: Follow-up 1: 6 - 10 weeks after the procedure
Procedural efficacy - Number of post-operative recurrences
Number of post-operative recurrences
Measured: Follow-up 1: 6 - 10 weeks after the procedure
Procedural efficacy - Number of participants with (serious) adverse events
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Measured: Follow-up 2: 12 months after the procedure
Procedural efficacy - Number of re-interventions
Number of re-interventions
Measured: Follow-up 2: 12 months after the procedure
Procedural efficacy - Number of post-operative recurrences
Number of post-operative recurrences
Measured: Follow-up 2: 12 months after the procedure
Procedural efficacy - Number of participants with (serious) adverse events
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Measured: Follow-up 3: 24 months after the procedure
Procedural efficacy - Number of re-interventions
Number of re-interventions
Measured: Follow-up 3: 24 months after procedure
Procedural efficacy - Number of post-operative recurrences
Number of post-operative recurrences
Measured: Follow-up 3: 24 months after the procedure
Procedural efficacy - Number of participants with (serious) adverse events
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Measured: Follow-up 4: 36 months after the procedure
Procedural efficacy - Number of re-interventions
Number of re-interventions
Measured: Follow-up 4: 36 months after the procedure
Procedural efficacy - Number of post-operative recurrences
Number of post-operative recurrences
Measured: Follow-up 4: 36 months after the procedure
Secondary outcomes (25)
Pre-operative abdominal pain by means of the Visual Analogue Scale (VAS)
Assessment of pre-operative abdominal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Measured: At baseline
Pre-operative vaginal pain by means of the Visual Analogue Scale (VAS)
Assessment of pre-operative vaginal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Measured: At baseline
Functional score - Obstructive Defecation Syndrome (ODS) score
The ODS score is obtained by means of a structured 8-item questionnaire on multiple bowel symptoms. The cumulative score for all answers ranges from 0 to 31, with higher scores being indicative of more severe symptoms.
Measured: At baseline
Functional score - Cleveland Clinical Incontinence Score (CCIS)
The CCIS is a 5-item questionnaire used to score the level of fecal incontinence. The cumulative score ranges from 0 to 20, with higher scores being indicative of more severe symptoms.
Measured: At baseline
Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)
The BBUSQ is a 22-item questionnaire to record data on 4 domains: constipation, evacuation, incontinence and urinary symptoms. Higher scores are indicative of more severe symptoms.
Measured: At baseline
Post-operative abdominal pain by means of the Visual Analogue Scale (VAS)
Assessment of post-operative abdominal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Measured: Follow-up 1: 6 - 10 weeks after the procedure
Post-operative abdominal pain by means of the Visual Analogue Scale (VAS)
Assessment of post-operative abdominal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Measured: Follow-up 2: 12 months after the procedure
Post-operative abdominal pain by means of the Visual Analogue Scale (VAS)
Assessment of post-operative abdominal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Measured: Follow-up 3: 24 months after the procedure
Post-operative abdominal pain by means of the Visual Analogue Scale (VAS)
Assessment of post-operative abdominal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Measured: Follow-up 4: 36 months after the procedure
Post-operative vaginal pain by means of the Visual Analogue Scale (VAS)
Assessment of post-operative vaginal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Measured: Follow-up 1: 6 - 10 weeks after the procedure
Post-operative vaginal pain by means of the Visual Analogue Scale (VAS)
Assessment of post-operative vaginal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Measured: Follow-up 2: 12 months after the procedure
Post-operative vaginal pain by means of the Visual Analogue Scale (VAS)
Assessment of post-operative vaginal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Measured: Follow-up 3: 24 months after the procedure
Post-operative vaginal pain by means of the Visual Analogue Scale (VAS)
Assessment of post-operative vaginal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Measured: Follow-up 4: 36 months after the procedure
Functional score - Obstructive Defecation Syndrome (ODS) score
The ODS score is obtained by means of a structured 8-item questionnaire on multiple bowel symptoms. The cumulative score for all answers ranges from 0 to 31, with higher scores being indicative of more severe symptoms.
Measured: Follow-up 1: 6 - 10 weeks after the procedure
Functional score - Obstructive Defecation Syndrome (ODS) score
The ODS score is obtained by means of a structured 8-item questionnaire on multiple bowel symptoms. The cumulative score for all answers ranges from 0 to 31, with higher scores being indicative of more severe symptoms.
Measured: Follow-up 2: 12 months after the procedure
Functional score - Obstructive Defecation Syndrome (ODS) score
The ODS score is obtained by means of a structured 8-item questionnaire on multiple bowel symptoms. The cumulative score for all answers ranges from 0 to 31, with higher scores being indicative of more severe symptoms.
Measured: Follow-up 3: 24 months after the procedure
Functional score - Obstructive Defecation Syndrome (ODS) score
The ODS score is obtained by means of a structured 8-item questionnaire on multiple bowel symptoms. The cumulative score for all answers ranges from 0 to 31, with higher scores being indicative of more severe symptoms.
Measured: Follow-up 4: 36 months after the procedure
Functional score - Cleveland Clinical Incontinence Score (CCIS)
The CCIS is a 5-item questionnaire used to score the level of fecal incontinence. The cumulative score ranges from 0 to 20, with higher scores being indicative of more severe symptoms.
Measured: Follow-up 1: 6 - 10 weeks after the procedure
Functional score - Cleveland Clinical Incontinence Score (CCIS)
The CCIS is a 5-item questionnaire used to score the level of fecal incontinence. The cumulative score ranges from 0 to 20, with higher scores being indicative of more severe symptoms.
Measured: Follow-up 2: 12 months after the procedure
Functional score - Cleveland Clinical Incontinence Score (CCIS)
The CCIS is a 5-item questionnaire used to score the level of fecal incontinence. The cumulative score ranges from 0 to 20, with higher scores being indicative of more severe symptoms.
Measured: Follow-up 3: 24 months after the procedure
Functional score - Cleveland Clinical Incontinence Score (CCIS)
The CCIS is a 5-item questionnaire used to score the level of fecal incontinence. The cumulative score ranges from 0 to 20, with higher scores being indicative of more severe symptoms.
Measured: Follow-up 4: 36 months after the procedure
Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)
The BBUSQ is a 22-item questionnaire to record data on 4 domains: constipation, evacuation, incontinence and urinary symptoms. Higher scores are indicative of more severe symptoms.
Measured: Follow-up 1: 6 - 10 weeks after the procedure
Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)
The BBUSQ is a 22-item questionnaire to record data on 4 domains: constipation, evacuation, incontinence and urinart symptoms. Higher scores are indicative of more severe symptoms.
Measured: Follow-up 2: 12 months after the procedure
Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)
The BBUSQ is a 22-item questionnaire to record data on 4 domains: constipation, evacuation, incontinence and urinary symptoms. Higher scores are indicative of more severe symptoms.
Measured: Follow-up 3: 24 months after the procedure
Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)
The BBUSQ is a 22-item questionnaire to record data on 4 domains: constipation, evacuation, incontinence and urinary symptoms. Higher scores are indicative of more severe symptoms.
Measured: Follow-up 4: 36 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start8 Feb 2021
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RectoceleStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Dams, MD, Principal investigator, Ziekenhuis Oost-Limburg (ZOL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564677
- Sponsor's protocol ID
- DM-ZOL-02
- Acronym
- POP-01
- Status last verified
- Oct 2023
- First submitted
- 3 Sep 2020
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy
- ClinicalTrials.gov ID
- NCT04564677
- Acronym / sponsor ID
- POP-01 / DM-ZOL-02
- Conditions
- Rectocele, Enterocele, Rectal Prolapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- DuomedIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Sep 2020 (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 observational study is to evaluate the clinical outcome of a modified d'Hoore technique for laparoscopic ventral mesh rectopexy in patients with primary rectal prolapse, rectocele and/or enterocele.The goal of the study will be achieved by reporting the peri- and postoperative complications ((serious) adverse events), recurrences and re-interventions. Pre-operative to postoperative changes in pain, functional outcome and quality of life will be evaluated as well.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients eligible for laparoscopic ventral mesh rectopexy | – | Device: Ifabond (Péters surgical)Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy (LVMR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy.
Key inclusion criteria (4 listed)
- Female patients.
- Patient ≥ 18 years of age at study entry.
- Patient and investigator signed and dated the informed consent form prior to the index-procedure.
- Patient with primary rectal prolapse (grades I to V according to the Oxford scale), rectocele and/or enterocele.
Key exclusion criteria (4 listed)
- Patient is unable / unwilling to provide informed consent.
- Patient with recurrent rectal prolapse, rectocele and/or enterocele.
- Patient is unable to comply with the study protocol or proposed follow-up visits.
- Patient has a contra-indication for laparoscopic ventral mesh rectopexy.
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 |
|---|---|---|
| Ifabond (Péters surgical)Ifabond (Péters surgical) is a CE-marked synthetic surgical glue for internal and external use. The glue is non-toxic, biocompatible and biodegradable. It is commercially available and can be used for mesh fixation, as tissue adhesive, for sealing of sutured tissue and for hemostasis. | Device | Patients eligible for laparoscopic ventral mesh rectopexy |
Primary outcome
Procedural efficacy - Number of participants with (serious) adverse events
Time frame: During procedure
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Procedural efficacy - Conversion rate to laparotomy during the index procedure
Time frame: During procedure
Number of conversions to laparotomy during the index procedure
Procedural efficacy - Number of participants with (serious) adverse events
Time frame: At discharge (assessed up to 1 week)
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Procedural efficacy - Number of re-interventions
Time frame: At discharge (assessed up to 1 week)
Number of re-interventions
Procedural efficacy - Number of participants with (serious) adverse events
Time frame: Follow-up 1: 6 - 10 weeks after the procedure
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Procedural efficacy - Number of re-interventions
Time frame: Follow-up 1: 6 - 10 weeks after the procedure
Number of re-interventions
Procedural efficacy - Number of post-operative recurrences
Time frame: Follow-up 1: 6 - 10 weeks after the procedure
Number of post-operative recurrences
Procedural efficacy - Number of participants with (serious) adverse events
Time frame: Follow-up 2: 12 months after the procedure
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Procedural efficacy - Number of re-interventions
Time frame: Follow-up 2: 12 months after the procedure
Number of re-interventions
Procedural efficacy - Number of post-operative recurrences
Time frame: Follow-up 2: 12 months after the procedure
Number of post-operative recurrences
Procedural efficacy - Number of participants with (serious) adverse events
Time frame: Follow-up 3: 24 months after the procedure
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Procedural efficacy - Number of re-interventions
Time frame: Follow-up 3: 24 months after procedure
Number of re-interventions
Procedural efficacy - Number of post-operative recurrences
Time frame: Follow-up 3: 24 months after the procedure
Number of post-operative recurrences
Procedural efficacy - Number of participants with (serious) adverse events
Time frame: Follow-up 4: 36 months after the procedure
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Procedural efficacy - Number of re-interventions
Time frame: Follow-up 4: 36 months after the procedure
Number of re-interventions
Procedural efficacy - Number of post-operative recurrences
Time frame: Follow-up 4: 36 months after the procedure
Number of post-operative recurrences
25 secondary outcomes
Pre-operative abdominal pain by means of the Visual Analogue Scale (VAS)
Time frame: At baseline
Pre-operative vaginal pain by means of the Visual Analogue Scale (VAS)
Time frame: At baseline
Functional score - Obstructive Defecation Syndrome (ODS) score
Time frame: At baseline
Functional score - Cleveland Clinical Incontinence Score (CCIS)
Time frame: At baseline
Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)
Time frame: At baseline
Post-operative abdominal pain by means of the Visual Analogue Scale (VAS)
Time frame: Follow-up 1: 6 - 10 weeks after the procedure
Post-operative abdominal pain by means of the Visual Analogue Scale (VAS)
Time frame: Follow-up 2: 12 months after the procedure
Post-operative abdominal pain by means of the Visual Analogue Scale (VAS)
Time frame: Follow-up 3: 24 months after the procedure
Post-operative abdominal pain by means of the Visual Analogue Scale (VAS)
Time frame: Follow-up 4: 36 months after the procedure
Post-operative vaginal pain by means of the Visual Analogue Scale (VAS)
Time frame: Follow-up 1: 6 - 10 weeks after the procedure
Post-operative vaginal pain by means of the Visual Analogue Scale (VAS)
Time frame: Follow-up 2: 12 months after the procedure
Post-operative vaginal pain by means of the Visual Analogue Scale (VAS)
Time frame: Follow-up 3: 24 months after the procedure
Post-operative vaginal pain by means of the Visual Analogue Scale (VAS)
Time frame: Follow-up 4: 36 months after the procedure
Functional score - Obstructive Defecation Syndrome (ODS) score
Time frame: Follow-up 1: 6 - 10 weeks after the procedure
Functional score - Obstructive Defecation Syndrome (ODS) score
Time frame: Follow-up 2: 12 months after the procedure
Functional score - Obstructive Defecation Syndrome (ODS) score
Time frame: Follow-up 3: 24 months after the procedure
Functional score - Obstructive Defecation Syndrome (ODS) score
Time frame: Follow-up 4: 36 months after the procedure
Functional score - Cleveland Clinical Incontinence Score (CCIS)
Time frame: Follow-up 1: 6 - 10 weeks after the procedure
Functional score - Cleveland Clinical Incontinence Score (CCIS)
Time frame: Follow-up 2: 12 months after the procedure
Functional score - Cleveland Clinical Incontinence Score (CCIS)
Time frame: Follow-up 3: 24 months after the procedure
Functional score - Cleveland Clinical Incontinence Score (CCIS)
Time frame: Follow-up 4: 36 months after the procedure
Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)
Time frame: Follow-up 1: 6 - 10 weeks after the procedure
Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)
Time frame: Follow-up 2: 12 months after the procedure
Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)
Time frame: Follow-up 3: 24 months after the procedure
Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)
Time frame: Follow-up 4: 36 months after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Anne Dams, MD principal investigator
Ziekenhuis Oost-Limburg (ZOL)
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 Rectocele and Enterocele, run by Duomed at 1 site in Belgium.
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 4 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: status not confirmed, as of the sponsor's last update on 10 Oct 2023. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephanie De Munter, PhD (+32 (0)11 28 69 48, stephanie.de.munter@archerresearch.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural efficacy - Number of participants with (serious) adverse events (time frame: During procedure). The study lists 16 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 10 Oct 2023.