Trial Outcomes & Findings for Post-market Clinical Follow-up Study of Reusable Clip Applier Cartridge Devices for LAParoscopic Surgery (NCT NCT05363813)
NCT ID: NCT05363813
Last Updated: 2026-08-04
Results Overview
Efficacy of long-term vessel/duct ligation defined as absence of Adverse Events (AEs) related to vessel and/or duct leakage due to incomplete ligation of the vessel/duct after appropriate placement of clip at 6 months of laparoscopic surgical procedures. Assessment of leakage was based on follow-up inquiry six months after the ligation procedure.
COMPLETED
NA
245 participants
6 months after laparoscopic surgical procedures
2026-08-04
Participant Flow
The RELAP clinical investigation enrolled subjects across six clinical sites in Spain and one in Portugal. First subject enrolled: 17-Oct-2022 in Complejo Hospitalario Universitario A Coruña Last subject enrolled: 16-Feb-2024 in Hospital Universitario y Politécnico La Fe. This study had an enrollment period of 487 days considering the range from FPI to Last Patient In LPI dates.
Of 245 enrolled subjects, one was implanted despite later being found to meet an exclusion criterion and remained in the Safety and ITT sets. Fourteen (14) others were not included in the study population due to withdrawal, conversion to open surgery, unfavorable anatomy, device issues, or lack of sterilized equipment, resulting in no device use.
Participant milestones
| Measure |
M/L-10 Multi-Fire Clip System (Single-arm)
Enrolled subjects that require a laparoscopic surgery and a clip can be used to occlude a vessel/duct.
|
|---|---|
|
Overall Study
STARTED
|
245
|
|
Overall Study
Intent-to-Treat (ITT) population
|
225
|
|
Overall Study
Safety Set population
|
231
|
|
Overall Study
Per-Protocol (PP) population
|
224
|
|
Overall Study
COMPLETED
|
222
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
M/L-10 Multi-Fire Clip System (Single-arm)
Enrolled subjects that require a laparoscopic surgery and a clip can be used to occlude a vessel/duct.
|
|---|---|
|
Overall Study
Consented, no treatment attempted
|
13
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Death
|
8
|
|
Overall Study
Treatment attempted, no clip implanted
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Safety Set Population
n=231 Participants
Includes all subjects who had any direct contact with the investigational device, regardless of eligibility status or treatment completion
|
|---|---|
|
Age, Continuous
|
60.96 years
STANDARD_DEVIATION 13.83 • n=231 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=231 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=231 Participants
|
|
Weight [kg]
|
84.97 Kg
STANDARD_DEVIATION 33.96 • n=231 Participants
|
|
Height [cm]
|
163.20 cm
STANDARD_DEVIATION 38.72 • n=231 Participants
|
|
Childbearing potential
Yes
|
9 Participants
n=231 Participants
|
|
Childbearing potential
No
|
222 Participants
n=231 Participants
|
|
Regular alcohol consumption
Yes
|
10 Participants
n=231 Participants • Some measures not reported by sites
|
|
Regular alcohol consumption
No
|
214 Participants
n=231 Participants • Some measures not reported by sites
|
|
Regular alcohol consumption
not reported patient data
|
7 Participants
n=231 Participants • Some measures not reported by sites
|
|
Regular smoker
Yes
|
22 Participants
n=231 Participants
|
|
Regular smoker
No
|
203 Participants
n=231 Participants
|
|
Regular smoker
Number of Subjects with missing Data
|
6 Participants
n=231 Participants
|
|
Cardiovascular history
Yes
|
123 Participants
n=231 Participants
|
|
Cardiovascular history
No
|
108 Participants
n=231 Participants
|
|
Ischemic heart disease
Yes
|
9 Participants
n=231 Participants
|
|
Ischemic heart disease
No
|
222 Participants
n=231 Participants
|
|
Hypertension
Yes
|
107 Participants
n=231 Participants
|
|
Hypertension
No
|
124 Participants
n=231 Participants
|
|
Stroke
Yes
|
4 Participants
n=231 Participants
|
|
Stroke
No
|
227 Participants
n=231 Participants
|
|
Coronary artery disease
Yes
|
10 Participants
n=231 Participants
|
|
Coronary artery disease
No
|
221 Participants
n=231 Participants
|
|
Peripheral vascular disease
Yes
|
4 Participants
n=231 Participants
|
|
Peripheral vascular disease
No
|
227 Participants
n=231 Participants
|
|
Other cardiovascular disease
Yes
|
28 Participants
n=231 Participants
|
|
Other cardiovascular disease
No
|
203 Participants
n=231 Participants
|
|
Coagulopathy
Yes
|
2 Participants
n=231 Participants
|
|
Coagulopathy
No
|
229 Participants
n=231 Participants
|
|
Hematologic disease
Yes
|
29 Participants
n=231 Participants
|
|
Hematologic disease
No
|
202 Participants
n=231 Participants
|
|
Pulmonary disease
Yes
|
49 Participants
n=231 Participants
|
|
Pulmonary disease
No
|
182 Participants
n=231 Participants
|
|
Lung fibrosis
Yes
|
1 Participants
n=231 Participants
|
|
Lung fibrosis
No
|
230 Participants
n=231 Participants
|
|
Respiratory failure
Yes
|
0 Participants
n=231 Participants
|
|
Respiratory failure
No
|
231 Participants
n=231 Participants
|
|
Chronic obstructive pulmonary disease (COPD)
Yes
|
28 Participants
n=231 Participants
|
|
Chronic obstructive pulmonary disease (COPD)
No
|
203 Participants
n=231 Participants
|
|
Asthma
Yes
|
11 Participants
n=231 Participants
|
|
Asthma
No
|
220 Participants
n=231 Participants
|
|
Other pulmonary disorder
Yes
|
16 Participants
n=231 Participants
|
|
Other pulmonary disorder
No
|
215 Participants
n=231 Participants
|
|
Renal disease
Yes
|
13 Participants
n=231 Participants
|
|
Renal disease
No
|
218 Participants
n=231 Participants
|
|
Gastrointestinal disease
Yes
|
31 Participants
n=231 Participants
|
|
Gastrointestinal disease
No
|
200 Participants
n=231 Participants
|
|
Chronic liver disease
Yes
|
6 Participants
n=231 Participants
|
|
Chronic liver disease
No
|
225 Participants
n=231 Participants
|
|
Inflammatory bowel disease (IBD)
Yes
|
18 Participants
n=231 Participants
|
|
Inflammatory bowel disease (IBD)
No
|
213 Participants
n=231 Participants
|
|
Other gastrointestinal diseases
Yes
|
4 Participants
n=231 Participants
|
|
Other gastrointestinal diseases
No
|
227 Participants
n=231 Participants
|
|
Hyperlipidaemia
Yes
|
82 Participants
n=231 Participants
|
|
Hyperlipidaemia
No
|
149 Participants
n=231 Participants
|
|
Diabetes
Yes
|
60 Participants
n=231 Participants
|
|
Diabetes
No
|
171 Participants
n=231 Participants
|
|
Connective tissue disorder
Yes
|
13 Participants
n=231 Participants
|
|
Connective tissue disorder
No
|
218 Participants
n=231 Participants
|
|
Previous non-laparoscopic/open abdominal surgery
Yes
|
29 Participants
n=231 Participants
|
|
Previous non-laparoscopic/open abdominal surgery
No
|
201 Participants
n=231 Participants
|
|
Previous non-laparoscopic/open abdominal surgery
Data Not Obtained
|
1 Participants
n=231 Participants
|
|
Gastric cancer
Yes
|
23 Participants
n=231 Participants
|
|
Gastric cancer
No
|
130 Participants
n=231 Participants
|
|
Gastric cancer
Yes, specifically gastrointestinal malignancies
|
78 Participants
n=231 Participants
|
|
History of allergy/hypersensitivity
Yes
|
36 Participants
n=231 Participants
|
|
History of allergy/hypersensitivity
No
|
195 Participants
n=231 Participants
|
|
Physical examination - Eyes
Number of subjects with normal system functioning
|
219 Participants
n=231 Participants
|
|
Physical examination - Eyes
Number of subjects with significant alterations
|
10 Participants
n=231 Participants
|
|
Physical examination - Eyes
Number of subjects with missing Data
|
2 Participants
n=231 Participants
|
|
Physical examination - Ears, nose, throat
Number of subjects with normal system functioning
|
227 Participants
n=231 Participants
|
|
Physical examination - Ears, nose, throat
Number of subjects with significant alterations
|
3 Participants
n=231 Participants
|
|
Physical examination - Ears, nose, throat
Number of Subjects with missing Data
|
1 Participants
n=231 Participants
|
|
Physical examination - Lymphatic system
Number of subjects with normal system functioning
|
206 Participants
n=231 Participants
|
|
Physical examination - Lymphatic system
Number of subjects with significant alterations
|
24 Participants
n=231 Participants
|
|
Physical examination - Lymphatic system
Number of Subjects with missing Data
|
1 Participants
n=231 Participants
|
|
Physical examination - Endocrine system
Number of subjects with normal system functioning
|
202 Participants
n=231 Participants
|
|
Physical examination - Endocrine system
Number of subjects with significant alterations
|
28 Participants
n=231 Participants
|
|
Physical examination - Endocrine system
Number of Subjects with missing Data
|
1 Participants
n=231 Participants
|
|
Physical examination - Lungs and respiratory tract
Number of subjects with normal system functioning
|
192 Participants
n=231 Participants
|
|
Physical examination - Lungs and respiratory tract
Number of subjects with significant alterations
|
38 Participants
n=231 Participants
|
|
Physical examination - Lungs and respiratory tract
Number of Subjects with missing Data
|
1 Participants
n=231 Participants
|
|
Physical examination - Peripheral vascular system
Number of subjects with normal system functioning
|
183 Participants
n=231 Participants
|
|
Physical examination - Peripheral vascular system
Number of subjects with significant alterations
|
47 Participants
n=231 Participants
|
|
Physical examination - Peripheral vascular system
Number of Subjects with missing Data
|
1 Participants
n=231 Participants
|
|
Physical examination - Cardiovascular system
Number of subjects with normal system functioning
|
183 Participants
n=231 Participants
|
|
Physical examination - Cardiovascular system
Number of subjects with significant alterations
|
47 Participants
n=231 Participants
|
|
Physical examination - Cardiovascular system
Number of Subjects with missing Data
|
1 Participants
n=231 Participants
|
|
Physical examination - Gastrointestinal tract, liver and spleen
Number of subjects with normal system functioning
|
158 Participants
n=231 Participants
|
|
Physical examination - Gastrointestinal tract, liver and spleen
Number of subjects with significant alterations
|
72 Participants
n=231 Participants
|
|
Physical examination - Gastrointestinal tract, liver and spleen
Number of Subjects with missing Data
|
1 Participants
n=231 Participants
|
|
Physical examination - Urogenital system
Number of subjects with normal system functioning
|
202 Participants
n=231 Participants
|
|
Physical examination - Urogenital system
Number of subjects with significant alterations
|
28 Participants
n=231 Participants
|
|
Physical examination - Urogenital system
Number of Subjects with missing Data
|
1 Participants
n=231 Participants
|
|
Physical examination - Nervous system
Number of subjects with normal system functioning
|
219 Participants
n=231 Participants
|
|
Physical examination - Nervous system
Number of subjects with significant alterations
|
11 Participants
n=231 Participants
|
|
Physical examination - Nervous system
Number of Subjects with missing Data
|
1 Participants
n=231 Participants
|
|
Physical examination - Muscular and skeletal system
Number of subjects with normal system functioning
|
211 Participants
n=231 Participants
|
|
Physical examination - Muscular and skeletal system
Number of subjects with significant alterations
|
19 Participants
n=231 Participants
|
|
Physical examination - Muscular and skeletal system
Number of Subjects with missing Data
|
1 Participants
n=231 Participants
|
|
Physical Examination - Skin and connective tissue
Number of Subjects with normal system functioning
|
224 Participants
n=231 Participants
|
|
Physical Examination - Skin and connective tissue
Number of subjects with significant alterations
|
6 Participants
n=231 Participants
|
|
Physical Examination - Skin and connective tissue
Number of Subjects with missing Data
|
1 Participants
n=231 Participants
|
PRIMARY outcome
Timeframe: 6 months after laparoscopic surgical proceduresPopulation: Per-Protocol (PP) populationconsist of subjects who met eligibility criteria, were implanted with at least one Multi-Fire clip, and completed the study without major protocol deviations (N=224). PP subjects who completed the 6-month follow-up visit was N=216 + PP subjects with leakage who did not complete the 6-month follow up (N=0).
Efficacy of long-term vessel/duct ligation defined as absence of Adverse Events (AEs) related to vessel and/or duct leakage due to incomplete ligation of the vessel/duct after appropriate placement of clip at 6 months of laparoscopic surgical procedures. Assessment of leakage was based on follow-up inquiry six months after the ligation procedure.
Outcome measures
| Measure |
Per-Protocol (PP) Population
n=216 Participants
Per-Protocol (PP) population is a subset of the ITT population consisting of subjects who met eligibility criteria, were implanted with at least one Multi-Fire clip, and completed the study without major protocol deviations. The PP subjects who completed the 6-month follow-up were 216.
|
|---|---|
|
No Post-Operative Leakage of Ligation Sites
Incidence
|
2 Participants
|
|
No Post-Operative Leakage of Ligation Sites
Effectiveness
|
214 Participants
|
SECONDARY outcome
Timeframe: 30-days follow-upPopulation: MAE related to the device or procedure divided by the number of subjects with follow-up at the corresponding timepoint (221 at 30 days; plus subjects who did not complete the visit but had already experienced the event (1 subject at 30 days).
MAEs are adverse events that can occur due to the operative procedure include, but are not limited to: * Major bleeding requiring reoperation * Septic shock from intraabdominal infection * Bowel injury requiring repair * Vascular injuries requiring repair * Genitourinary injuries requiring repair * Biliary injuries requiring repair * Retained foreign body, which is a patient safety incident in which a surgical object is accidentally left in a body cavity or operation wound following a procedure. MAES can also occur due to Anesthesia include, but are not limited to: * Cerebrovascular Accident (Stroke) * Myocardial Infarction * Pulmonary Embolism (PE) * Blood clots A Risk Ratio (RR) will be defined for the analysis of this secondary endpoint.
Outcome measures
| Measure |
Per-Protocol (PP) Population
n=222 Participants
Per-Protocol (PP) population is a subset of the ITT population consisting of subjects who met eligibility criteria, were implanted with at least one Multi-Fire clip, and completed the study without major protocol deviations. The PP subjects who completed the 6-month follow-up were 216.
|
|---|---|
|
Long-term Evaluation of Major Adverse Events (MAEs) Related to the Medical Device or Procedure With 30-days Follow-up
|
13 events
|
SECONDARY outcome
Timeframe: 30 days follow-up follow-up after laparoscopic surgical proceduresPopulation: SAEs related to the device or procedure divided by the number of subjects with follow-up at the corresponding timepoint (221 at 30 days), plus subjects who did not complete the visit but had already experienced the event (1 subject at 30 days).
SAEs are Adverse Events (AEs) that meet any of the criteria below: 1. Led to a death, 2. Led to a serious deterioration in health of the subject, that either resulted in 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure or a body function, or 3. in-patient hospitalization or prolongation of existing hospitalization, or 4. medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function. 5. chronic disease
Outcome measures
| Measure |
Per-Protocol (PP) Population
n=222 Participants
Per-Protocol (PP) population is a subset of the ITT population consisting of subjects who met eligibility criteria, were implanted with at least one Multi-Fire clip, and completed the study without major protocol deviations. The PP subjects who completed the 6-month follow-up were 216.
|
|---|---|
|
All Serious Adverse Events (SAEs) With 30 Days Follow-up
|
16 Events
|
SECONDARY outcome
Timeframe: 6-months follow-upPopulation: MAE related to the device or procedure divided by the number of subjects with follow-up at the corresponding timepoint ( 218 at 6 months), plus subjects who did not complete the visit but had already experienced the event ( 1 subject at 6 months)
MAEs are adverse events that can occur due to the operative procedure include, but are not limited to: * Major bleeding requiring reoperation * Septic shock from intraabdominal infection * Bowel injury requiring repair * Vascular injuries requiring repair * Genitourinary injuries requiring repair * Biliary injuries requiring repair * Retained foreign body, which is a patient safety incident in which a surgical object is accidentally left in a body cavity or operation wound following a procedure. MAES can also occur due to Anesthesia include, but are not limited to: * Cerebrovascular Accident (Stroke) * Myocardial Infarction * Pulmonary Embolism (PE) * Blood clots A Risk Ratio (RR) will be defined for the analysis of this secondary endpoint.
Outcome measures
| Measure |
Per-Protocol (PP) Population
n=219 Participants
Per-Protocol (PP) population is a subset of the ITT population consisting of subjects who met eligibility criteria, were implanted with at least one Multi-Fire clip, and completed the study without major protocol deviations. The PP subjects who completed the 6-month follow-up were 216.
|
|---|---|
|
Long-term Evaluation of Major Adverse Events (MAES) Related to the Medical Device or Procedure With 6-month Follow-up
|
15 Events
|
SECONDARY outcome
Timeframe: One day (during procedure)Population: 17 subjects (7.58%) experienced procedure-related SAEs during the same 24-hour postoperative period, reflecting the APS performance of the surgical intervention.
The Acute Procedural Success (APS) is defined as the absence of (S)AEs related to the procedure during the first 24 hours.
Outcome measures
| Measure |
Per-Protocol (PP) Population
n=224 Participants
Per-Protocol (PP) population is a subset of the ITT population consisting of subjects who met eligibility criteria, were implanted with at least one Multi-Fire clip, and completed the study without major protocol deviations. The PP subjects who completed the 6-month follow-up were 216.
|
|---|---|
|
Acute Procedural Success (APS)
|
17 Participants
|
SECONDARY outcome
Timeframe: One day (during procedure)Population: Only 2 of the 224 subjects in the Per-Protocol population (0.89%) experienced a device-related serious adverse event (SAE) within the first 24 hours after surgery.
Acute Device Success (ADS) is defined as absence of (S)AEs related to the device during the first 24h after procedure.
Outcome measures
| Measure |
Per-Protocol (PP) Population
n=224 Participants
Per-Protocol (PP) population is a subset of the ITT population consisting of subjects who met eligibility criteria, were implanted with at least one Multi-Fire clip, and completed the study without major protocol deviations. The PP subjects who completed the 6-month follow-up were 216.
|
|---|---|
|
Acute Device Success (ADS)
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 30 daysPatient's length of Stay (LoS) in hospital from day of admission to hospital discharge after laparoscopic surgical procedure.
Outcome measures
| Measure |
Per-Protocol (PP) Population
n=224 Participants
Per-Protocol (PP) population is a subset of the ITT population consisting of subjects who met eligibility criteria, were implanted with at least one Multi-Fire clip, and completed the study without major protocol deviations. The PP subjects who completed the 6-month follow-up were 216.
|
|---|---|
|
Length of Stay (LoS) in Hospital
|
5.75 Days
Standard Deviation 25.07
|
SECONDARY outcome
Timeframe: 6 month follow-up after laparoscopic surgical proceduresPopulation: SAEs related to the device or procedure divided by the number of subjects with follow-up at the corresponding timepoint ( 218 at 6 months), plus subjects who did not complete the visit but had already experienced the event ( 1 subject at 6 months).
SAEs are Adverse Events (AEs) that meet any of the criteria below: 1. Led to a death, 2. Led to a serious deterioration in health of the subject, that either resulted in 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure or a body function, or 3. in-patient hospitalization or prolongation of existing hospitalization, or 4. medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function. 5. chronic disease
Outcome measures
| Measure |
Per-Protocol (PP) Population
n=219 Participants
Per-Protocol (PP) population is a subset of the ITT population consisting of subjects who met eligibility criteria, were implanted with at least one Multi-Fire clip, and completed the study without major protocol deviations. The PP subjects who completed the 6-month follow-up were 216.
|
|---|---|
|
All Serious Adverse Events (SAEs) With 6 Months Follow-up
|
19 Events
|
Adverse Events
Safety Set Population
Serious adverse events
| Measure |
Safety Set Population
n=231 participants at risk
Includes those subjects who have been in direct contact with the medical devices, regardless of whether the subject does not fulfill the eligibility criteria, or the treatment is not successfully completed.
|
|---|---|
|
Gastrointestinal disorders
Gastrointestinal
|
12.6%
29/231 • Subject enrollment until end of follow-up, up to 6- month
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
0.87%
2/231 • Subject enrollment until end of follow-up, up to 6- month
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Track
|
0.87%
2/231 • Subject enrollment until end of follow-up, up to 6- month
|
|
Vascular disorders
Peripheral Vascular
|
5.2%
12/231 • Subject enrollment until end of follow-up, up to 6- month
|
|
Cardiac disorders
Cardiovascular
|
1.7%
4/231 • Subject enrollment until end of follow-up, up to 6- month
|
|
Hepatobiliary disorders
Hepatic
|
0.43%
1/231 • Subject enrollment until end of follow-up, up to 6- month
|
|
Reproductive system and breast disorders
Urogenital
|
3.0%
7/231 • Subject enrollment until end of follow-up, up to 6- month
|
|
Musculoskeletal and connective tissue disorders
Muscular
|
0.43%
1/231 • Subject enrollment until end of follow-up, up to 6- month
|
|
Skin and subcutaneous tissue disorders
Skin affection
|
3.5%
8/231 • Subject enrollment until end of follow-up, up to 6- month
|
|
Skin and subcutaneous tissue disorders
Connective tissue affection
|
0.43%
1/231 • Subject enrollment until end of follow-up, up to 6- month
|
|
General disorders
Other
|
2.6%
6/231 • Subject enrollment until end of follow-up, up to 6- month
|
Other adverse events
| Measure |
Safety Set Population
n=231 participants at risk
Includes those subjects who have been in direct contact with the medical devices, regardless of whether the subject does not fulfill the eligibility criteria, or the treatment is not successfully completed.
|
|---|---|
|
General disorders
Non-serious Adverse Event
|
10.4%
24/231 • Subject enrollment until end of follow-up, up to 6- month
|
|
General disorders
Major Adverse Events
|
10.0%
23/231 • Subject enrollment until end of follow-up, up to 6- month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place