Clinical trials

9

Search and review clinical trials. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Auricular Vagus Nerve Stimulation in Patients With High Impact Chronic Low Back Pain

The goal of this clinical trial is to evaluate whether auricular vagus nerve stimulation using the VIVO® device can improve function and reduce pain in adults with high-impact chronic low back pain when added to standard medical care. It will also assess the safety and usability of this therapy. The study includes adult patients aged 30 to 55 years who have had moderate to severe chronic low back pain for more than 6 months and who did not experience sufficient relief with standard pain treatments. The main questions this study aims to answer are: * Does adding the VIVO® device to standard care help people function better in daily life? * Does the VIVO® device help lower pain and improve wellbeing, sleep, and quality of life? Researchers will compare standard care plus VIVO® to standard care alone to see if the device improves outcomes. Standard care may include medication, physiotherapy, or other usual treatments. The main outcome is the change in disability (measured using the Oswestry Disability Index) after 6 weeks of treatment. Participants will: * Attend a baseline visit where medical history, physical examination, and questionnaires about pain, function, mood, sleep, and quality of life are collected; * Be randomly assigned to one of the two treatment groups; * Attend weekly visits for 6 weeks during the treatment phase; * Keep a diary of their pain levels and any treatments or medications used; * Complete questionnaires about pain, function, sleep, and wellbeing during the study. Participants in the intervention group will: Receive a VIVO® wearable device applied to the ear, which delivers electrical stimulation to the vagus nerve; Use the device continuously over 6 weeks, with weekly replacement and adjustment of stimulation settings; Be able to adjust the stimulation intensity themselves using a handheld device. After the treatment period, all participants will be followed for 12 months, with additional visits or contacts to assess long-term effects, safety, and sustainability of the treatment.

Participants needed: 44
Trial details
Age: 30-60Biological sex: AllType: InterventionalSponsor: Algemeen Ziekenhuis Maria MiddelaresUpdated: Jul 2, 2026Locations: 1
Eligibility criteria

Male or female patients aged ≥ 30 and ≤ 60 years; [+5]

Organic low back pain (trauma, fracture, tumor, infection, documented severe deg... [+27]

Status: Not yet recruiting

Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall heRnias (ROCSTAR)

In the treatment of ventral incisional hernias, a mesh repair in the retromuscular plane is considered as the gold standard. To allow for adequate medialization of the fascial borders and a complete closure of the defect in case of large incisional hernias, component separation techniques are increasingly being used. When compared to anterior component separation, posterior component separation by transversus abdominis release (TAR) seems to decrease postoperative wound problems. While laparoscopic techniques pose significant difficulties to perform TAR minimally invasively (mainly due to ergonomic and technical reasons), these limitations seem to be overcome by robotic platforms. Initial retrospective patient series report on significantly shorter postoperative hospital stay and fewer complications after robotic transversus abdominis release (rTAR), when compared to open transversus abdominis release (oTAR). High-quality prospective evidence on rTAR is currently lacking.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Algemeen Ziekenhuis Maria MiddelaresUpdated: Apr 11, 2025
Eligibility criteria

Pregnant or suspected pregnancy [+11]

Status: Recruiting

Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair

Evaluate the early postoperative course of patients undergoing laparoscopic inguinal hernia repair with either a conventional or a robot assisted approach and with or without the injection of the trocar wounds with a local anesthetic.

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Algemeen Ziekenhuis Maria MiddelaresUpdated: Apr 11, 2025Locations: 1
Eligibility criteria

adult patients presenting with a bilateral inguinal hernia planned for a minimal...

Age below 18 years [+7]

Status: Recruiting

Laparoscopic Groin Hernia Repair by a 3D ENDOLAP Visible Mesh With or Without LiquiBand Fix 8 Mesh Fixation

This study aims to visualize the implanted mesh in vivo by MRI in 20 patients at 1 month and 12 months post-operatively. Moreover, we want to evaluate the safety and efficiency of non-penetration mesh fixation techniques using pre-designed ENDOLAP 3D visible mesh placement versus mesh fixation using a synthetic LiquiBand Fix 8 glue for laparoscopic treatment of groin hernias. A total of 100 male and female patients will be entered in the trial in Maria Middelares Ghent, for which an inclusion period of 24 months is anticipated. Four surgeons of the department of surgery will screen all eligible consecutive patients for inclusion in the study. They will inform all patients about the surgery and the follow-up with MRI scan thereafter.

Participants needed: 100
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: Algemeen Ziekenhuis Maria MiddelaresUpdated: Apr 11, 2025Locations: 1
Eligibility criteria

adult patients presenting with primary unilateral inguinal hernia [+1]

Age below 18 years [+8]

Status: Recruiting

High-resolution PET-CT Specimen Imaging for the Perioperative Visualization of Resection Margins

These are patients in whom a benign or malignant tumor was recorded requiring surgery. During that surgery, the surgeon will cut away the tumor as part of the treatment of the disease. In this process, it is important that the tumor is removed correctly and completely. To verify that the correct tissue was completely removed, the tissue is examined microscopically. However, a microscopic analysis takes a relatively long time and the result is not known until a few days after the surgery is completed. If that microscopic analysis should eventually reveal that the tumor was not completely removed, additional treatment is usually necessary. An assessment of the excised tissue during surgery would allow additional tissue to be excised in the same operation if necessary. Thus, in this way, additional treatments can also be avoided. This could lead to shorter treatment time and less emotional strain for the patient, as well as lower costs. To date, however, there are no effective techniques to do this. PositronEmissionTomography (PET) imaging can be used to image the tumor that needs to be excised. To do this, a tracer must be administered through the blood before the operation. This tracer is a slightly radioactive substance that can be detected by the PET camera even at low concentrations. This technique is already routinely used in the hospital to detect cancer or inflammatory tissue in the body. During this study, however, it's not the intention to look at the tumor while it is still in the patient's body, but rather after it has been cut out of the patient's body by the surgeon. To do this, the piece of tissue cut away will be scanned using a specially designed PET-CT scanner. The overall goal of this study is to gain additional knowledge. More specifically, the investigators wish to determine which medical conditions may benefit from high-resolution PET-CT specimen imaging.

Participants needed: 150
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Algemeen Ziekenhuis Maria MiddelaresUpdated: Feb 19, 2025Locations: 1
Eligibility criteria

able to understand treatment protocol and informed consent form [+14]

general or local contra-indications for resective surgery; [+3]

Status: Recruiting

Goal-directed Fluid Therapy During Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction

Adequate free flap perfusion during Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction surgery requires maintaining blood pressure above 100 mmHg and avoiding excessive fluid administration. This study aims to determine whether the use of a measurement of preload dependency (Pulse Pressure Variation = PPV), can guide fluid therapy and if it decreases the risk of flap oedema. For this purpose, two fluid management strategies will be compared: * Static intraoperative fluid management: Administration of crystalloid fluids is limited to 5ml/kg/h * Dynamic intraoperative fluid management: Crystalloid fluids are only administered if PPV exceeds 12% The purpose of this study is to compare the static and dynamic (= targeted) fluid strategy and to evaluate the effect on flap oedema and flap perfusion.

Participants needed: 82
Trial details
Phase: Phase 4Age: 18-70Biological sex: FemaleType: InterventionalSponsor: Algemeen Ziekenhuis Maria MiddelaresUpdated: Jan 28, 2025Locations: 1
Eligibility criteria

Female adult patients, between 18 and 70 years of age [+2]

present atrial fibrillation (AF) [+7]

Status: Not yet recruiting

Rapid Move Following Outpatient Surgery: Safety and Patient Characteristics

A descriptive, retrospective cohort study will be conducted to gain insight in the safety of the Rapid Move. The trial will include a group of Rapid Move patients, who were transferred to the Rapid Move after their outpatient surgery and subsequently discharged home. The Rapid Move is a short-stay PACU where patients recover from anaesthesia, are continuously monitored, and prepared for discharge within an hour after surgery.

Participants needed: 1,500
Trial details
Age: 15+Biological sex: AllType: ObservationalSponsor: Algemeen Ziekenhuis Maria MiddelaresUpdated: Dec 19, 2024Locations: 1
Eligibility criteria

Patients aged 15 years or older; [+1]

Inpatients defined as a patient who is formally admitted (or "hospitalized") to... [+1]

Status: Recruiting

SetUp Study for HugoTM RAS Inguinal Hernia Repair

The goal of this observational cohort study is to evaluate the evolution of the operative time in performing robotic assisted laparoscopic inguinal hernia repair (rTAPP) during the learning curve of the first 50 patients using the HugoTM Ras (Medtronic) robotic system using the setup guide. Researchers will compare to the operative time for rTAPP of 50 patients by the same surgeon in another hospital using the daVinci Xi (Intuitive Surgical) robotic system.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Algemeen Ziekenhuis Maria MiddelaresUpdated: Sep 19, 2024Locations: 2
Eligibility criteria

Recurrent hernias after previous preperitoneal mesh placement. [+5]

Status: Recruiting

Interpectoral-pectoserratus Plane Block for Minimally Invasive Aortic Valve Replacement Via Right Anterior Minithoracotomy

The goal of this clinical trial is to evaluate the analgesic effect of locoregional anaesthesia, specifically the interpectoral pectoserratus plane (IPP-PSP) block, in comparison to a placebo (sham block) after Aortic Valve Replacement via Right Anterior Minithoracotomy (AVR-RAT). The main question the trial aims to answer is: Can the IPP-PSP block effectively reduce opioid consumption within the first 48 hours after AVR-RAT surgery? The purpose is to understand the impact of the IPP-PSP block on postoperative pain. Therefore, the aim is to investigate the influence of the IPP-PSP block on the amount of pain medication administered during the patients' first 48 hours after surgery. Participants, who are scheduled for AVR-RAT surgery, will be randomly assigned to receive either the IPP-PSP block or the sham block. Researchers will compare opioid consumption among other outcomes, including differences in pain scores, incidence of nausea and vomiting, quality of recovery, quality of life, and the length of hospital stay between the two groups. Patients will be monitored during their hospitalization, and a follow-up phone call will be conducted 30 days after surgery.

Participants needed: 144
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Algemeen Ziekenhuis Maria MiddelaresUpdated: Sep 19, 2024Locations: 1
Eligibility criteria

Adult patients (18 years of age or older); [+4]

BMI > 35; [+18]